Although Pfizer (NYSE:PFE) has yet to receive emergency use authorization for its Paxlovid COVID-19 therapy, it plans to manufacture 80 million courses of the drug by the end of 2022. Pfizer had initially planned on making 50 million courses of Paxlovid (PF-07321332/ritonavir) in the same time frame.
An interim analysis of the Phase 2/3 EPIC-HR study found the drug to be 89% effective at reducing hospitalization or death. Pfizer announced the launch of a Phase 1 study of PF-07321332 in March.
Pfizer has inked a $5.29 billion Paxlovid deal with the U.S. government.
One course of oral Paxlovid therapy would consist of two daily 150-mg doses for five days.
Meanwhile, molnupiravir, the antiviral from Merck (NYSE:MRK) and Ridgeback Biotherapeutics, has lost some of its luster. New data suggests the drug led to an absolute risk reduction against hospitalization or death of 3% compared to placebo. Furthermore, the drug led to a relative risk reduction of 30%. Earlier data suggested that the drug offered a 50% relative risk reduction.
FDA advisors will meet tomorrow to discuss whether the benefits of molnupiravir outweigh the risks.
Pfizer announced in mid-November that it had filed paperwork with the FDA for emergency use authorization of Paxlovid. The company is also seeking market authorization for the drug candidate in the European Union.