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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.

The Food and Drug Administration could approve Novavax’s Covid-19 vaccine for emergencies as early as May, the company’s CEO Stanley Erck told CNBC on Monday.

Novavax’s Phase 3 trial in the US with 30,000 participants is ongoing, Erck said. The company hopes the FDA will allow it to use data from its UK clinical trial when it files its emergency use application later this year, he added.

The UK health authorities are likely to review the vaccine in April, followed by the FDA “probably a month after,” he said in an interview with CNBC’s “Closing Bell”.

That schedule could be postponed for a month or two while the FDA waits for the U.S. trial dates, he said.

Novavax is among several companies working to develop vaccines against the virus, which on Monday infected more than 114 million people worldwide and killed at least 2.53 million people, according to Johns Hopkins University. Three vaccines – from Pfizer, Moderna, and Johnson & Johnson – have so far been approved for use in the United States.

In late January, Novavax released results of its Phase 3 trial data in the UK, showing that the vaccine was 89.3% overall effective, despite being used against B.1.1.7, the strain first discovered in the UK, and B.1.351 was a little less effective. the tribe first discovered in South Africa.

The company said the vaccine was well tolerated, adding that “serious, serious and medically treated adverse events occurred in low levels and were balanced between vaccine and placebo groups”.

Novavax has signed a contract with the US government to supply 110 million cans. The company could complete those shipments in June or July, Erck said.

If the company’s vaccine is approved in the US, it doesn’t worry about demand, even though three vaccines are already widely available.

“The US has a huge need for vaccines and it’s a big world,” he said, adding the company has commitments for 200 million doses elsewhere.