Tag: Drug

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F.D.A. Approves Xywav, a GHB drug, for Uncommon Sleeping Dysfunction

F.D.A. Approves Xywav, a GHB drug, for Rare Sleeping Disorder

On the black market, homemade GHB — also known as liquid ecstasy, goop and G — can be bought by the capful for $5 to $25. But nightly treatments of Xyrem and Xywav cost roughly $100,000 a year. The new approval will make it much easier for hypersomnia patients to get insurance coverage for Xywav.

Many doctors and patients have never heard of idiopathic hypersomnia, Mr. Cozadd said, but Jazz will aim to change that. “There’s an educational effort that we’ll be part of,” he said, “which is really making sure there’s a better understanding among treaters and among patients of the condition and its treatment.”

The F.D.A. said its decision was significant because it is the first drug approved to treat the disorder.

“Idiopathic hypersomnia is a lifelong condition, and the approval of Xywav will be instrumental in providing treatment for symptoms such as excessive sleepiness and difficulty waking, and in effectively managing this debilitating disorder,” said Dr. Eric Bastings, deputy director of the agency’s Office of Neuroscience, in a statement.

In March, Jazz and the Hypersomnia Foundation, a patient advocacy group, began an awareness campaign — “I have IH” — which included an online survey of health care providers’ knowledge of the condition (it was low), and advertisements in Times Square.

“I never thought I’d live to see that day — it was very emotional,” said Betsy Ashcraft, the treasurer of the foundation’s board of directors, whose adult son has idiopathic hypersomnia. (Jazz paid the foundation for board members’ time consulting on the campaign, she said.)

GHB is an old drug, first synthesized by a Russian chemist in 1874. A century later, it was sold as a dietary supplement in the United States, and academic researchers began reporting that it greatly improved the nighttime sleep of people with narcolepsy and curbed their daytime attacks of paralysis, called cataplexy.

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Biogen’s controversial Alzheimer’s drug generates $2 million gross sales in first few weeks after approval

Biogen's controversial Alzheimer’s drug generates $2 million sales in first few weeks after approval

Aduhelm from Biogen

Source: Biogen

Biogen’s Alzheimer’s drug Aduhelm made $ 2 million in sales in the first few weeks after its approval, the company said Thursday when it released its second quarter results along with an open letter about the controversial drug.

Biogen increased its sales guidance for the year and expected total sales for the year of $ 10.65 billion to $ 10.85 billion. That’s an increase from its earlier estimates of $ 10.45 billion to $ 10.75 billion. The new forecast assumes “modest” income for Aduhelm in 2021, which will then be ramped up, the company said.

Here’s how Biogen performed in the three months ended June 30, compared to Wall Street’s expectations, according to Refinitiv’s average estimates:

  • Adjusted earnings per share: $ 5.68 versus $ 4.54 expected
  • Revenue: $ 2.78 billion versus an expected $ 2.61 billion

The company’s stock rose slightly in early trading.

Aduhelm was approved by the Food and Drug Administration on June 7th. The drug, scientifically known as aducanumab, offers new hope to friends and families of patients living with the disease and is set to generate billions in revenue for the company.

However, its approval has since been questioned, and the head of the FDA is now calling for a state investigation into the interactions between agency employees and the biotech company.

Biogen’s Chief Research Officer, Dr. Al Sandrock, defended the drug in an open letter released Thursday along with the company’s profits, saying its approval was subject to “extensive misinformation and misunderstanding”.

He said it was “normal” for scientists and clinicians to discuss and debate data from experimental and clinical trials, but added that those discussions had taken a turn “outside the boundaries of legitimate scientific reasoning”.

“We welcome a formal review of the interactions between the FDA and Biogen in the process of obtaining aducanumab approval,” said Sandrock. “A better understanding of the facts is good for everyone involved in building confidence in the therapy and the approval process as we prioritize the issues that affect patients.”

Correction: In an earlier version, Aduhelm was misspelled.

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Drug Distributors and J.&J. Attain $26 Billion Deal to Finish Opioids Lawsuits

Drug Distributors and J.&J. Reach $26 Billion Deal to End Opioids Lawsuits

After two years of wrangling, the country’s three major drug distributors and a pharmaceutical giant have reached a $26 billion deal with states that would release some of the biggest companies in the industry from all legal liability in the opioid epidemic, a decades-long public health crisis that has killed hundreds of thousands of Americans.

The announcement was made Wednesday afternoon by a bipartisan group of state attorneys general.

The offer will now go out to every state and municipality in the country for approval. If enough of them formally sign on to it, billions of dollars from the companies could begin to be released to help communities pay for addiction treatment and prevention services and other steep financial costs of the epidemic.

In return, the states and cities would drop thousands of lawsuits against the companies and pledge not to bring any future action.

The settlement binds only these four companies — the drug distributors Cardinal Health, AmerisourceBergen, McKesson, and Johnson & Johnson — leaving thousands of other lawsuits against many other pharmaceutical defendants, including manufacturers and drugstore chains, in the mammoth nationwide litigation still unresolved.

But these four companies are widely seen as among the defendants with the deepest pockets.

In an emailed statement, Michael Ullmann, executive vice president and general counsel of Johnson & Johnson, said: “We recognize the opioid crisis is a tremendously complex public health issue, and we have deep sympathy for everyone affected. This settlement will directly support state and local efforts to make meaningful progress in addressing the opioid crisis in the United States.”

In a joint statement, the three distributors said: “While the companies strongly dispute the allegations made in these lawsuits, they believe the proposed settlement agreement and settlement process it establishes are important steps toward achieving broad resolution of governmental opioid claims and delivering meaningful relief to communities across the United States.”

The distributors, which by law are supposed to monitor quantities of prescription drug shipments, have been accused of turning a blind eye for two decades while pharmacies across the country ordered millions of pills for their communities. Plaintiffs also allege that Johnson & Johnson, which used to contract with poppy growers in Tasmania to supply opioid materials to manufacturers and made its own fentanyl patches for pain patients, downplayed addictive properties to doctors as well as patients.

According to federal data, from 1999 to 2019, 500,000 people died from overdoses to prescription and street opioids. Overdose deaths from opioids hit a record high in 2020, the Centers for Disease Control and Prevention said earlier this month.

Under the agreement, the country’s three distributors would make payments over 18 years. Johnson & Johnson would pay $5 billion over nine years. A key feature of the agreement is that the distributors would establish an independent clearinghouse to track and report one another’s shipments, a new and unusual mechanism intended to make data transparent and send up red flags immediately when outsized orders are made.

A separate deal between the companies and Native American tribes is still being negotiated.

The agreement was presented by attorneys general from North Carolina, Pennsylvania, New York, Delaware, Louisiana, Tennessee and Connecticut.

Wednesday’s announcement suggests that a critical element — a large majority of states agreeing in principle — has been met. But there are daunting obstacles remaining before any checks are actually cut.

The states and the District of Columbia will now have 30 days to closely review the agreement, including how much each would be paid over 17 years. Many states have not yet had the chance to scrutinize the deal. And while many permit their attorneys general to sign off, others require that legislators must be consulted. An unspecified number of states must sign on, for the deal to proceed. If that threshold is not met, the companies could walk away.

While the states are deciding, a trial brought by several California counties in state court against Johnson & Johnson and a local West Virginia trial in federal court against the distributors will continue.

States also have to begin cajoling their localities, including those that have already filed cases and those that have not, to agree to the deal. The greater the number of local governments that sign on, the greater the amount of money each state will receive.

“The lawyers will do a lot of the strong-arming of their clients, the localities, into agreeing to the settlements, because if the deal doesn’t go through, the lawyers won’t get paid,” said Elizabeth Burch, a law professor at the University of Georgia who has followed the litigation closely.

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How an Unproven Alzheimer’s Drug Acquired Authorized

How an Unproven Alzheimer’s Drug Got Approved

The idea of accelerated approval came up briefly toward the end, raised by Dr. Rick Pazdur, head of F.D.A.’s oncology center, who was not a council member. It was not discussed in detail, but after the meeting, given the council’s rejection of standard approval, accelerated approval appeared to be the only way to make the drug available.

On April 26, Dr. Patrizia Cavazzoni, Dr. Dunn’s boss and director of the Center for Drug Evaluation and Research, led a smaller meeting about accelerated approval, which had never been used for Alzheimer’s drugs.

In fact, the F.D.A.’s most recent guidance for Alzheimer’s drugs, issued by Dr. Dunn in 2018, says “the standard for accelerated approval” had not yet been met for the disease, “despite a great deal of research.” The guidance says that is because “there is unfortunately at present no sufficiently reliable evidence” that attacking amyloid plaques or other biomarkers of Alzheimer’s “would be reasonably likely to predict clinical benefit.”

And at the November advisory committee meeting, Dr. Dunn said that in considering whether to approve aducanumab, “we’re not using the amyloid as a surrogate for efficacy.”

Under accelerated approval, while a drug is on the market, a company must conduct an additional trial, a costly undertaking. Biogen said its goal was standard approval, which it believed its data warranted.

At the April 26 meeting, Dr. Cavazzoni invited two officials not involved with neurological drugs who had used accelerated approval frequently: Dr. Pazdur and Dr. Peter Marks, the top vaccine regulator. They and Dr. Cavazzoni voted to grant such approval to aducanumab, as did Dr. Issam Zineh, director of the Office of Pharmacology, and Dr. Jacqueline Corrigan-Curay, who led the internal review of the F.D.A-Biogen collaboration.

The director of the office of translational sciences, Dr. ShaAvhrée Buckman-Garner — who supervises both the pharmacology and biostatistics offices — did not vote yes or no, saying she understood both arguments. The only clear no vote, F.D.A. documents say, was the director of the office of biostatistics, Dr. Sylva Collins, “stating her belief that there is insufficient evidence to support accelerated approval or any other type of approval.”

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Ease of Covid lockdown restrictions could assist diminish drug abuse, physician says

Ease of Covid lockdown restrictions may help diminish drug abuse, doctor says

The number of deaths from drug overdose in the United States hit a dismal record as the nation battled the Covid-19 pandemic at the same time. In 2020, a total of 93,331 Americans died from drug overdoses, an increase of nearly 30% year over year, according to preliminary data from the Centers for Disease Control and Prevention.

Dr. Nora Volkow, director of the National Institute on Drug Abuse, told CNBC’s The News with Shepard Smith that she hopes the surge in drug overdoses will not last.

“One of the reasons I’m optimistic … is that one of the factors that contributed to this surge in drug use was isolation and social distancing, and that doesn’t allow you to give Narcan, which reverses overdoses,” said Volkow. “This desperation, which I hope people felt, is slowly being alleviated.”

Volkow added that people will now be able to rebuild social support systems that existed before the Covid pandemic and that health systems can focus again on treating opioid abuse disorders.

The US also had the highest number of deaths from opioid overdoses in 2020, and more than 60% of those deaths were related to fentanyl. Moderator Shepard Smith asked Volkow why fentanyl played such a role in drug overdoses. Volkow stated that it had to do with potency and pricing.

“Fentanyl is a very potent drug, and it’s actually 50 times more potent than heroin, so you need smaller amounts to get the same effects,” said Volkow. “So it is actually a big win for the illicit drug market, and it has been used to actually contaminate other drugs. So when you mix fentanyl with drugs like methamphetamine or cocaine, you make them so much more deadly. “

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Ohio Clinic Says It Will not Administer Alzheimer’s Drug to Sufferers

Ohio Clinic Says It Won't Administer Alzheimer's Drug to Patients

In a conspicuous concern about the approval of the controversial new Alzheimer’s drug Aduhelm, the Cleveland Clinic said Wednesday evening that it would not give it to patients.

The clinic, one of the largest and most respected medical centers in the country, said in a statement a panel of experts had “reviewed all available scientific evidence about this drug,” also called aducanumab.

“Based on the current data on safety and effectiveness, we have decided not to wear aducanumab at the moment,” the statement said.

A spokeswoman for the clinic said individual doctors there could prescribe Aduhelm to patients, but those patients would have to go elsewhere to get the drug, which is given as an intravenous infusion every month.

The stance of the major medical center is the latest fallout from the approval of the drug by the Food and Drug Administration on June 7, a decision that also fueled Congressional investigations.

Many Alzheimer’s experts and other scientists have said that it is unclear that the drug helps slow cognitive decline and that at best the evidence suggests only a slight slowdown while showing that Aduhelm causes brain swelling or hemorrhage could.

Recognition…Biogen, via Associated Press

The drug is also expensive. Biogen, the maker, has set its price at $ 56,000 per year.

In a recent survey of nearly 200 neurologists and primary care physicians, most said they disagreed with the FDA’s decision and did not plan to prescribe the drug to their patients.

Last week, Dr. Janet Woodcock, acting FDA commissioner, in response to growing criticism of an independent state investigation into the agency’s regulatory process, wrote, “To the extent that these concerns could undermine public confidence in the FDA’s decision, I believe” it is critically important that the disputed events are reviewed by an independent body. “

Two almost identical clinical trials with Aduhelm were stopped prematurely because an independent data monitoring committee concluded that the drug did not appear to be helping patients. A later analysis by Biogen found that participants who received the high dose of the drug in one study experienced a very slight slowdown in cognitive decline – 0.39 on an 18-point scale – that participants in the other study however, had not benefited from it at all.

About 40 percent of study participants developed cerebral hemorrhage or swelling, and while most of these cases were mild or manageable, about 6 percent of participants dropped out because of serious side effects from these conditions.

After reviewing the data late last year, an FDA advisory committee strongly recommended outside experts against approval, and three of its members resigned in protest last month when the agency defied the advice of the advisory committee. The American Geriatrics Society had also urged the agency not to approve the drug because it was “premature in the absence of sufficient evidence.”

In response to widespread criticism that Aduhelm was approved for anyone with Alzheimer’s, the FDA last week severely restricted the drug’s recommended use, saying that it should only be used for people with mild memory or thinking problems as it doesn’t have any Data on the use of Aduhelm gave later stages of Alzheimer’s disease.

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Biden to Nominate Rahul Gupta to Run Nationwide Workplace of Drug Management Coverage

Biden to Nominate Rahul Gupta to Run National Office of Drug Control Policy

Charleston’s program was nationally recognized, but it was criticized by the city’s mayor when Dr. Gupta was the health commissioner. Dr. Gupta’s department issued an audit that found fault with the program, including shoddy record keeping, which led to the program’s decertification after the city had already shut it down.

Public health experts said its closure had a chilling effect on other programs, and kept some from getting off the ground.

As a state health official, Dr. Gupta had no authority to stop the closure. In a 2018 interview with West Virginia Public Broadcasting shortly before he left the health commissioner’s job, Dr. Gupta said that the closure was “not in the best interest of the community” and that needle exchange programs like Charleston’s should not be shut down “reactively.”

But critics faulted him for not using his platform forcefully enough to defend the program.

Gregg Gonsalves, an epidemiologist at Yale University and a longtime AIDS activist, on Tuesday called Dr. Gupta a “terrible choice” who “represents a return to the old ways of thinking about drug use in America, and is not the forward-thinking leader we need right now.”

Other experts said that Dr. Gupta was caught in a difficult situation with the battle over the syringe exchange. Mr. Raymond, while describing the closure of the Charleston program as “a tragedy,” called Dr. Gupta an “excellent choice.” That assessment was echoed by Dr. Joshua M. Sharfstein, a public health expert at Johns Hopkins Bloomberg School of Public Health who worked with Dr. Gupta to address the opioid crisis in West Virginia.

“He knows the value of syringe service programs, he understands the evidence on harm reduction and he is very supportive,” Dr. Sharfstein said. “West Virginia is a very difficult environment for discussion of these topics, and he had to navigate under those constraints.”

The White House announced the selection of Dr. Gupta in a statement on Tuesday, along with 10 other nominations, including that of Jeff Flake, the former Republican senator from Arizona, to be the ambassador to Turkey and that of the writer Atul Gawande to a post at the U.S. Agency for International Development.

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Politics

Police arrest Four on varied weapons and drug prices at Denver resort

Police arrest 4 on various weapons and drug charges at Denver hotel

A general view of the stadium in the third inning during a game between the Colorado Rockies and the Los Angeles Dodgers at Coors Field on April 4, 2021 in Denver, Colorado.

Justin Edmonds | Getty Images

Denver police arrested three men and a woman on various weapons and drug charges Friday night at a downtown Denver hotel near events connected to the upcoming Major League Baseball All-Star Game, police said Saturday.

Officers responded to a report about a “suspicious occurrence” at the Maven Hotel, which is a block from Coors Field. They obtained search warrants for two rooms and found evidence, as well as impounded two vehicles, according to the department.

A spokeswoman for the Federal Bureau of Investigation Denver Field Office told NBC News that the agency “has no reason to believe there was any threat directed at the MLB All-Star Game.” Coors Field is set to host the game on Tuesday.

Police said the investigation is active and ongoing and have not yet released details about the evidence. The department told CNBC on Sunday that it’s unable to provide additional details due to the ongoing investigation but confirmed it’s working with local and federal law enforcement partners on the probe.

The three men were charged with possession of a weapon by a previous offender. Two of the men and the woman were charged with possession of a controlled substance with the intent to distribute. One of the men and the woman were also wanted on warrants from another jurisdiction.

“The investigation and arrests were the result of a tip from the public, serving as an excellent example of the critical role the community plays in public safety,” Denver police said in a news release. “DPD encourages residents and visitors to always be aware of their surroundings and to report suspicious or illegal activity to police immediately.”

Correction: This story has been updated to reflect that the four suspects were arrested at the Maven Hotel on various combinations of charges.

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F.D.A. Requests Federal Investigation of Alzheimer’s Drug Approval

F.D.A. Requests Federal Investigation of Alzheimer’s Drug Approval

The Food and Drug Administration on Friday called for a federal investigation into the process that led to the approval of a new drug for Alzheimer’s disease that has sparked harsh criticism from lawmakers and the medical community.

In a letter to the independent office of the Inspector General of the Department of Health, Acting Commissioner of the FDA, Dr. Janet Woodcock, the scrutiny the agency has been through regarding the approval process for the drug known as Aduhelm. She pointed to interactions between representatives from drug developer Biogen and the agency, saying that some “may have occurred outside of the formal correspondence process”.

“To the extent that these concerns could undermine public confidence in the FDA’s decision, I believe it is critical that the disputed events be verified by an independent body,” wrote Dr. Woodcock. She noted that the review should investigate whether communications between agency staff and Biogen representatives violated FDA rules.

The unusual request to examine the decision-making process of one’s own employees for an individual drug approval is likely to exacerbate the controversy surrounding the approval of Aduhelm. The FDA approved the drug a month ago, overcoming stout objections from its own independent advisors who said there wasn’t enough evidence to know if the drug was effective.

After the decision, three of these experts left an FDA advisory panel.

Dr. Woodcock’s request for an investigation came a day after the FDA narrowed its recommendations on who should receive the drug. After initially being recommended for all Alzheimer’s patients, the agency’s new guidelines should only prescribe it to people with mild cognitive problems.

Biogen did not immediately respond to a request for comment.

STAT, the medical news organization, first reported that Dr. Billy Dunn, the agency’s head of neuroscience, in early May 2019 held an off-the-book meeting with a Biogen manager, Dr. Al Sandrock, exit. While it is not uncommon for pharmaceutical company executives to meet frequently with FDA officials, it is uncommon to provide data that would be part of an FDA application outside of a formal framework.

A few months earlier, Biogen had discontinued two late-stage studies of the drug after early analysis found the drug would not prove effective. However, the Biogen researchers who analyzed the data soon concluded that the decision to stop the studies was premature and that the drug might be effective after all.

The meeting between Dr. Dunn and Dr. Sandrock was a first step in resuming the talks that led to approval last month.

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A New Alzheimer’s Drug Gives Extra Questions Than Solutions

A New Alzheimer’s Drug Offers More Questions Than Answers

“It puts us in a bad place,” agreed Dr. Karina Bishop, a geriatrician at the University of Nebraska Medical Center. Ethically, she added, “if this drug was available right now, I would not feel able to prescribe it.”

Even as individual doctors grapple with advising patients, hospitals and health systems are devising protocols for when Aduhelm becomes available, probably within weeks.

At the Mayo Clinic, said Dr. Ronald Petersen, a neurologist who directs the Alzheimer’s Disease Research Center there, “we’re going to stick pretty close to the inclusion and exclusion criteria used in the trial.”

That means only patients with mild cognitive impairment or early Alzheimer’s disease would qualify, after an M.R.I. to rule out certain conditions and risks, and a P.E.T. scan or lumbar puncture to confirm the presence of amyloid. The Mayo protocols, like the clinical trials, would exclude people taking blood thinners like Warfarin or Eliquis.

“It’s not like you come in and say, ‘I’m a little forgetful,’ and we say, ‘Here’s this drug,’” said Dr. Petersen. But not every provider, he acknowledged, will employ such safeguards.

Dr. Eric Widera, a geriatrician at the University of California, San Francisco, expressed a similar concern: “If doctors were extremely cautious and limited this drug to the very specific population included in the study, with very careful monitoring, it would be the first time in medicine that was ever done.”

He pointed out another consequence of federal approval: a rift between some doctors and the Alzheimer’s Association, the national advocacy group, which this spring mounted a campaign it called More Time. Intended to demonstrate public support for approval of aducanumab, the effort included newspaper ads and social media posts.