Tag: Regeneron

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Regeneron to request FDA clearance for antibody drug as preventative remedy

Regeneron to request FDA clearance for antibody drug as preventative treatment

View of Regeneron Pharmaceuticals corporate, research and development headquarters on Old Saw Mill River Road in Tarrytown, New York.

Lev Radin | LightRocket | Getty Images

Regeneron Pharmaceuticals announced Monday that it would ask the Food and Drug Administration to approve the use of its Covid-19 antibody therapy as a preventative treatment.

The therapy, given to former President Donald Trump shortly after he was diagnosed with Covid-19 last year, has already been approved by the FDA to treat adults with mild to moderate Covid-19 and pediatric patients aged 12 and over approved age who tested positive for the virus and is at high risk of serious illness.

Regeneron said it plans to expand the use of its treatment in the United States after a Phase 3 clinical study jointly conducted by the National Institutes of Health found the drug reduced the risk of symptomatic infections in individuals by 81%.

The company also said that people who were symptomatic and treated with the drug resolved their symptoms an average of two weeks faster than those who received a placebo.

“As more than 60,000 Americans continue to be diagnosed with COVID-19 every day, the REGEN-COV antibody cocktail can help provide immediate protection to unvaccinated people exposed to the virus,” said Dr. George Yancopoulos, President and Chief Scientific Officer of Regeneron, said in a press release.

The study included 1,505 people who were not infected with the virus but lived in the same household as someone who recently tested positive. Participants received either a dose of Regeneron therapy or a placebo.

The company said 41% of the people in the study were Hispanic and 9% were Black. Additionally, 33% of the participants were obese and 38% were 50 years and older, according to the company.

Regeneron therapy belongs to a class of treatments known as monoclonal antibodies, which act as immune cells to fight infections. Monoclonal antibody treatments attracted widespread attention after it was revealed that Trump had received Regeneron’s drug in October.

In recent months, public health officials have raised concerns that emerging, highly contagious variants of coronavirus could threaten monoclonal antibodies on the market. Dr. However, Myron Cohen, who leads monoclonal antibody efforts for the NIH-sponsored COVID Prevention Network, said the drug has shown that it will retain its effectiveness against new strains.

As the world’s attention has shifted to giving Covid-19 vaccines, health experts say treatments are also crucial to ending the pandemic, which, according to compiled data, has topped 31.1 million in just over a year Infected Americans and killed at least 561,800 people from Johns Hopkins University.

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West Virginia mistakenly provides 42 individuals Regeneron IV Covid therapy as a substitute of vaccine shot

West Virginia mistakenly gives 42 people Regeneron IV Covid treatment instead of vaccine shot

A pharmacist dilutes the Pfizer COVID-19 vaccine as he prepares it for administration to staff and residents at Goodwin House Bailey’s Crossroads, a senior community in Falls Church, Virginia, on December 30, 2020.

Brendan Smialowski | AFP | Getty Images

Dozens of people in West Virginia were mistakenly given Regeneron’s Covid-19 antibodies instead of the Moderna vaccine, the West Virginia National Guard said Thursday.

According to the state’s National Guard, 42 people received the intravenous treatment at a Boone County Department of Health vaccination clinic. The National Guard said it learned of the mistake on Wednesday.

Everyone who received the antibody treatment instead of the vaccine, which is given through a shot in the arm, has been contacted, Julie Miller, a Boone County Health Department administrator, told CNBC via email. She added, “We don’t think there is any risk of harm.”

Regeneron’s monoclonal antibody treatment, which must be given via an IV drip, is seen as a promising treatment for Covid-19 – especially if given early in the course of the infection. But the West Virginia mix-up is just one example of the confusion in the rush to distribute the vaccine to tens of millions of people. The rollout was slower than expected and was characterized by logistical challenges.

“It was determined that this was an isolated incident,” Miller said. “All those affected will be offered the COVID-19 vaccine today.”

She said the health department will work closely with the state National Guard and the Department of Health and Human Resources to review their policies and procedures.

Miller did not provide details on what caused the mix-up.

Representatives from the West Virginia National Guard and the West Virginia Governor’s Office did not respond to CNBC’s request for further comment on the occurrence of the error.

Maj. Gen. James Hoyer, adjutant general of the West Virginia National Guard, said in a statement that his forces “acted immediately” to correct the mistake as soon as they found out what happened. “We immediately reviewed and strengthened our logs to improve our sales process and prevent this from happening again,” he said in a statement.

He added that the state will continue to promote the vaccine “to save more lives every day”.

Dr. Clay Marsh, the state’s Covid-19 tsar, noted in a statement that the Regeneron treatment mistakenly given in place of the vaccine is the same product “that was given to President Trump when he became infected”.

“Although this injection is not harmful, it has replaced the vaccine,” he said. “However, this event provides an important opportunity for our leadership team to review and improve the safety and vaccination process for every West Virginian.”