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THURSDAY, December 01, 2022
Pfizer seeks emergency authorization for its coronavirus-fighting pill regimen

Pfizer seeks emergency authorization for its coronavirus-fighting pill regimen

WEDNESDAY, November 17, 2021

Pharmaceutical giant Pfizer requested emergency authorization Tuesday for its five-day antiviral pill regimen, Paxlovid, making it the second easy-to-take treatment aimed at keeping newly infected people out of the hospital to go before the Food and Drug Administration.

Pfizer's submission came shortly after the company announced that the clinical trial testing the drug regimen had been halted early due to overwhelming evidence that it worked. When Paxlovid was given to people at high risk of severe illness within three days of symptom onset, it reduced the rate of death and hospitalization by 89% compared with people given a placebo.

Pfizer is requesting authorization for people who are at increased risk of hospitalization due to age or underlying medical conditions, and the submission will add to a busy holiday season for regulators. The clinical trial did not include people who fell sick after being vaccinated, but the FDA will decide on the final eligible population and usage of the drug.

Scientists at the Food and Drug Administration are already poring over the data on molnupiravir, an antiviral pill developed by Merck and its partner Ridgeback Biotherapeutics that cut risk of hospitalization and death in half in a clinical trial that was also stopped early because the drug was clearly effective. An external advisory committee to the agency is scheduled to meet Nov. 30 to discuss the safety and effectiveness of molnupiravir.

An agency spokeswoman did not immediately respond to questions about the possible timing of an advisory committee meeting focused on the Pfizer drug.

Pfizer is also testing its medicine in people who are at low risk of severe outcomes and in people who have been exposed to the virus, which could eventually lead to broader use.

Pfizer's Paxlovid is a combination of a new molecule developed specifically to disable SARS-CoV-2 and ritonavir, an HIV medication that helps slow the breakdown of the coronavirus-specific drug. The company has begun manufacturing and packaging the drug in factories in Ireland, Germany and Italy and has projected having 180,000 pill packs available by the end of the year and 50 million in 2022.

The Washington Post reported that the Biden administration is set to announce this week that it has procured 10 million courses of treatment.

Pfizer has also licensed its drug to the United Nations-backed Medicines Patent Pool, which could increase access in poorer countries where half the world's population lives. Lower-income countries would pay a not-for-profit price, according to Pfizer and the Medicines Patent Pool.

The Biden administration has also pre-purchased 3.1 million treatment courses of molnupiravir at a cost of $2.2 billion. Merck has forecast having 10 million treatment courses available by the end of the year and has also licensed its drug to the Medicines Patent Pool.