Pfizer Is Submitting Its Covid Antiviral To The FDA For Emergency Authorization

Pfizer announced Tuesday that it has submitted its antiviral drug Paxlovid for emergency authorization with the FDA. The news comes just a few days after it announced that interim analysis of clinical study data found the drug to be effective at preventing severe cases of Covid-19.

“We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients,” Pfizer CEO Albert Bourla said in a statement. “And we look forward to working with the U.S. FDA on its review of our application, along with other regulatory agencies around the world.”

Paxlovid is an antiviral drug of a class called a protease inhibitor. It specifically targets proteins located in the coronavirus that causes Covid in order to slow down the replication of the virus. This reduces the viral load in a patient, making it less likely they’ll contract a severe form of the disease.

Earlier this month, Pfizer announced that its clinical studies of the drug determined that it was 89% effective and preventing hospitalizations and deaths for infected Covid patients compared to a placebo.

Pfizer’s antiviral pill isn’t the only one nearly ready to hit the market. Merck and its partner Ridgeback Therapeutics have also developed an antiviral pill, which it requested emergency authorization for last month. That drug, molnupiravir, works differently than Pfizer’s, but was also shown to be effective at preventing severe disease.

Both Pfizer and Merck’s drugs, if authorized, would help fill a need in the market for an oral pill that can be taken to prevent severe disease. Currently, the only other treatments for mild to moderate Covid are monoclonal antibodies, which, while effective, have to be delivered through injection or infusion, making them difficult to deliver into some areas.

Earlier today, Pfizer had announced it’s entered into an agreement with the UN-backed Medicines Patent Pool that would allow generics manufacturers in 95 different countries to produce Paxlovid without paying royalties to Pfizer so long as the pandemic is ongoing. The Biden Administration is also reportedly planning to announce it’s buying 10 million doses of the antiviral medication.

“The overwhelming efficacy achieved in our recent clinical study of Paxlovid, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against Covid-19,” Bourla said.

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