Data For Pfizer’s COVID-19 Drug Shows No Possible Association With Infection Rebound

The FDA dropped in briefing document as the agency’s external advisors meet on Thursday (March 16) to discuss complete approval…
  • The FDA dropped in briefing document as the agency’s external advisors meet on Thursday (March 16) to discuss complete approval for Pfizer Inc’s (NYSE:PFE) 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.
  • Related: Shionogi’s COVID-19 Pill, Based On Similar Action Like Pfizer’s, Sees Around $2B In Annual Sales.
  • 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.
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