FDA Says Study Needed To Assess Another Round Of Pfizer's COVID-19 Pill As Infection Rebounds

The FDA has asked Pfizer Inc PFE to test an additional course of its antiviral Paxlovid among people who experience a rebound in COVID-19 after treatment.
According to the Reuters report, the company must produce the initial results of a randomized controlled trial of a second course of the antiviral by September 30 next year.
The National Institutes of Health studied 13,644 COVID-19 patients treated with Paxlovid or Merck & Co Inc's MRK molnupiravir within five days of their COVID-19 infection.
Related: Pfizer Seeks Complete Approval For Paxlovid For High-Risk COVID-19 Patients.
The 7-day and 30-day rebound rates after Paxlovid treatment were 3.53% and 5.40% for COVID-19 infection, 2.31% and 5.87% for COVID-19 symptoms, and 0.44% and 0.77% for hospitalizations.
The rates after molnupiravir treatment - 5.86% and 8.59%, 3.75% and 8.21%, and 0.84% and 1.39%.
The study concluded that COVID-19 rebound occurred 2 to 8 days after Paxlovid and molnupiravir, especially in patients with underlying medical conditions.
The investigators suggest studies are necessary to determine the mechanisms underlying COVID-19 rebounds and to test dosing and duration regimes that might prevent such rebounds in vulnerable patients.
In May, the FDA did not support the idea of taking more Paxlovid in case the infection rebounded.
The FDA said a protocol for the study is expected to be finalized this month.
Pfizer is "working with the FDA to finalize a protocol to study patients who may require retreatment" and will provide details when available, a company spokesperson said.
Price Action: PFE shares are down 0.51% at $48.90 during the premarket session on the last check Monday.

Market News and Data brought to you by Benzinga APIs

Comments

Popular Channels

Tools & Features

Partners & Contributors

About Benzinga