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The FDA dropped in briefing document as the agency’s external advisors meet on Thursday (March 16) to discuss complete approval for Pfizer Inc’sPFE Covid-19 treatment drug Paxlovid.
Data from the drug’s trials support its use in adults at high risk of progressing to severe disease.
Paxlovid has shown a reduced risk of hospitalization or death by 86% in non-hospitalized, high-risk adult patients in Pfizer’s study, which did not include vaccinated participants.
The agency document also mentioned that more data are needed to determine if longer Paxlovid dosing may be optimal for mild-to-moderate COVID-19 in immunocompromised patients.
Pfizer is conducting a randomized controlled trial to evaluate different durations of Paxlovid treatment in immunocompromised patients with mild-to-moderate COVID-19. Topline data is expected by the end of September.
There have been multiple reports on COVID rebounds in some people after taking Paxlovid.
However, overall rates of symptom rebound ranged from 10% to 16%, with no evidence of a higher rebound rate in patients who received the drug or the placebo, regardless of their risk of severe disease or whether Omicron or an earlier variant was dominant.
In 2022, Pfizer reported Paxlovid sales of $18.83 billion, and it expects just $8 billion in 2023.
Price Action: PFE shares are down 0.36% at $39.72 on the last check Tuesday.
