Pfizer's megablockbuster-to-be COVID pill Paxlovid scores FDA nod

In the years-long battle against COVID-19, has a new age dawned with the emergence of antiviral pills to fight infection?

On Wednesday, the FDA sanctioned Pfizer’s Paxlovid for emergency use. The drug is a highly anticipated oral medicine for recently infected individuals who are at a high risk of progressing to a severe form of the disease. For Pfizer, the authorization will bring another massive pandemic windfall.

With the omicron variant surging around the world and two previously reliable antibody treatments showing little effectiveness against the new strain, the authorization comes at a crucial time in the pandemic fight.

The pill has been hailed as a potential game-changer because of its efficacy, relatively low cost and ease of administration. A study of Paxlovid—a protease inhibitor which keeps the virus from replicating—showed it reduced the risk of hospitalization and death by 89%.

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Pfizer has agreed to supply the U.S. with 10 million courses of Paxlovid for $5.29 billion ($529 per course). On Wednesday, the company also revealed it will supply 2.5 million courses to the U.K. on top of a previous agreement for 250,000 courses.

"Today’s authorization of Paxlovid represents another tremendous example of how science will help us ultimately defeat this pandemic, which, even two years in, continues to disrupt and devastate lives across the world," Pfizer CEO Albert Bourla said in a statement.

A month ago, SVB Leerink analyst Geoffrey Porges projected the drug will generate $24.2 billion in 2022 sales. Together with the company's megablockbuster COVID-19 vaccine Comirnaty, Pfizer could be looking at $50 billion in peak pandemic vaccine and drug sales, Cantor Fitzgerald analyst Louise Chen wrote earlier this month.

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Pfizer CEO Bourla recently said the company can manufacture 80 million courses in 2022, with 30 million available in the first half of the year. 

A course of the treatment is 20 Paxlovid pills and 10 ritonavir pills taken over five days. Ritonavir is an HIV drug that acts as a booster for Paxlovid, keeping it active inside a person's body.

With the authorization, Pfizer beat another developer of an oral antiviral to the finish line. Merck and Ridgeback’s pill—which was originally developed two decades ago to treat the flu—has been shown in a trial to reduce the risk of hospitalization and death by 30%. While molnupiravir was approved in the U.K. in early November, U.S. regulators have waited for more data on its safety.