Pfizer Stock (NYSE:PFE)
The Food and Drug Administration (FDA) announced on Tuesday that the oral COVID therapy Paxlovid manufactured by Pfizer (NYSE:PFE) is not associated with symptom rebound and that the antiviral maintains its activity against the Omicron variant. This information comes ahead of an advisory committee meeting that will be held later this week. Despite that, Pfizer stock declined in the market.
The FDA granted emergency use authorization for Paxlovid in 2021 to treat mild-to-moderate COVID-19 in people aged 12 years and older who are at risk of developing the severe form of the illness. Paxlovid combines the protease inhibitor nirmatrelvir and the older antiviral ritonavir.
The Antimicrobial Medicines Advisory Committee of the FDA will hold a meeting on March 16 to evaluate the company’s marketing application for its complete clearance.
The FDA has suggestions from its advisory groups, but these recommendations are not legally binding. On the other hand, the regulatory body will often follow them before settling on a final judgment on authorizations.
The FDA staff issued briefing materials before the meeting. They emphasized that despite a paucity of clinical evidence to support its clinical effectiveness in high-risk adults infected with Omicron, nonclinical and clinical studies suggest that Paxlovid maintains its antiviral action against the variation.
The Food and Drug Administration (FDA) also remarked on instances of COVID rebound that were connected to the medication, saying that “extensive assessments” conducted by the agency and Pfizer didn’t “find a clear relationship” between Paxlovid and symptom return.
However, the Food and Drug Administration (FDA) states that there are now two clinical investigations that will establish the incidence of COVID rebound in immunologically weaker patients after various durations of therapy and identify the potential benefit of employing Paxlovid retreatment to address the problem. These clinical trials are currently underway.