FDA to authorize COVID-19 pills this week: Bloomberg

The U.S. Food and Drug Administration (FDA) is expected to authorize two COVID-19 treatment pills, people familiar with the matter told Bloomberg.

The treatments would include Pfizer’s pill, Paxlovid, as well as Merck’s molnupiravir, which are meant to treat higher-risk COVID-19 patients, according to Bloomberg. 

The people who spoke to the outlet said the approval could come as soon as Wednesday, though they acknowledged that the plan was subject to change. 

As part of the authorization, the agency could limit who is permitted to use the pills. While the pills are not expected to be widely available in the immediate future, the U.S. has ordered 10 million of the Pfizer pill and roughly 3 million of Merck’s, Bloomberg added.

“It’s the biggest thing to happen in the pandemic after vaccines,” Eric Topol, director of the Scripps Research Translational Institute, said to Bloomberg, noting that the end-of-year announcement was not typical of the FDA and signaled the importance of the treatment options.

Last month, an advisory group narrowly voted to recommend that the FDA authorize Merck’s pill for high-risk adults. Research has suggested that the company’s pill reduced the risk of hospitalization by 50 percent. 

Bloomberg reported that clinical studies have shown Pfizer’s pill to be even more effective, reducing the chances of hospitalization by 89 percent for patients who took the pill within three days of their symptoms.

Meanwhile, the effectiveness of Pfizer’s pill is expected to be met with great demand for the treatment, perhaps even more than the company’s supply of pills can handle. 

Pfizer has said it expects to have 180,000 courses of the treatment available by the end of the year and 80 million by the end of next year. 

The Hill has reached out to the FDA for comment.