Pfizer gears up for Paxlovid new drug application submission to FDA

The most popular COVID-19 antiviral is Paxlovid (nirmatrelvir [PF-07321332] and ritonavir). The manufacturer of the drug, Pfizer Inc. (NYSE: PFE), anticipates selling about $22 billion worth of Paxlovid this year.

Complicating matters, however, is the failure of the drug to meet its primary endpoint of self-reported, sustained alleviation of all COVID-19 symptoms for four consecutive days in the EPIC-SR study.

In a press release describing the gathering of new data to support a new drug application submission, Pfizer noted that EPIC-SR data from standard-risk vaccinated and unvaccinated patients were not statistically significant but underscored its efficacy overall.

In the EPIC-SR study, the drug passed the statistically significant threshold of reducing COVID-19-related medical visits per day compared to placebo by 62%. In addition, the study found a non-significant 70% relative risk reduction for the key secondary endpoint of hospitalization or death.…

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Pfizer to make COVID-19 pill available in low- and middle-income nations

In late October, Merck (NYSE:MRK) and its partner Ridgeback Biotherapeutics agreed to make the COVID-19 antiviral molnupiravir available in the developing world.

Now, Pfizer (NYSE:PFE) is taking a similar approach for its investigational antiviral cocktail Paxlovid, which contains PF-07321332 and ritonavir.

Pfizer, like Merck, struck an agreement with the Medicines Patent Pool (MPP) related to Paxlovid.

MPP’s mission is to expand low- and middle-income countries’ access to vital medicines. The United Nations supports the organization.

Pfizer announced earlier this month that Paxlovid was 89% effective in reducing the risk of hospitalization or death in an interim analysis of the Phase 2/3 EPIC-HR trial.

The collaboration with MPP will enable generic drug makers internationally with sub-licenses to produce Paxlovid for use in 95 countries, which comprise more than half of the world’s population.

“This license is so important because, …

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