FDA advisory panel supports full approval of Pfizer’s COVID therapy

USA —Advisers to the U.S. Food and Drug Administration gave strong support for full approval of Pfizer’s oral antiviral COVID-19 treatment, Paxlovid, for adults at high risk of severe disease progression.

The FDA panel, comprised of external experts, voted 16 to 1 in favor of the drug’s benefits outweighing the risks for adults with mild-to-moderate COVID-19.

The agency is expected to reach a formal decision on approval by May and typically follows the recommendations of its expert panel, although it is not obligated to do so.

Once fully approved, Pfizer will be able to sell Paxlovid, a two-drug pill combination, on the private market in the U.S. at market rates instead of through government contracts, as has been the case thus far.

Pfizer has already sold almost 24 million courses of Paxlovid to the U.S. government at approximately US$530 per course.

As of March 12, the U.S. government had distributed around 12.7 million courses, and over 8.5 million courses have been dispensed, according to government data.

In December 2021, the FDA granted emergency use authorization for Paxlovid in high-risk individuals aged 12 and above.

Pfizer then submitted an application for full approval in June 2022, but the FDA extended its review period for the application in December.

Drawing on three mid-to-late stage clinical trials conducted by Pfizer, which involved over 6,000 patients from 21 countries, the panel overwhelmingly voted 16-1 to recommend full approval of Paxlovid.

Paxlovid comprises of two drugs: nirmatrelvir, which blocks a crucial enzyme that the Covid virus requires to replicate, and ritonavir, which enhances the efficacy of the first drug in fighting the infection.

Patients who experience Covid symptoms take Paxlovid within five days to decrease the risk of hospitalization or death. A full course of Paxlovid requires patients to take three pills twice a day for five days.

Before the FDA panel’s vote, the agency staff expressed the need for additional data to determine if immunocompromised individuals require an extended course of Paxlovid beyond the conventional five-day treatment.

The staff noted the scarcity of clinical trial data on Paxlovid’s use in immunocompromised patients, citing only 13 out of over 2,000 patients in the EPIC-HR trial with weakened immune systems.

According to the FDA staff, longer courses of Paxlovid may benefit immunocompromised individuals more since they are prone to prolonged Covid infections.

The Centers for Disease Control and Prevention states that immunocompromised patients may remain contagious beyond 20 days after developing symptoms and recommends isolation for at least 20 days.

Roughly 7 million adults in the United States are immunocompromised, as per the CDC estimates.

Pfizer representatives highlighted their company’s ongoing efforts to investigate the use of Paxlovid in immunocompromised patients.

In September, the company initiated clinical trials to explore varying durations of Paxlovid treatment, including 10- and 15-day courses.

Earlier, the FDA announced that the existing emergency use authorization (EUA) for Paxlovid in high-risk adolescents would continue to be effective even if the drug receives full approval for use in older patients.

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