FDA Granted full Approval to Pfizer’s COVID Antiviral Pill, Paxlovid, for adults

(CTN News) – The Food and Drug Administration (FDA) has granted full approval to Pfizer’s antiviral Paxlovid for treating mild to moderate COVID-19 in high-risk adults.

The approval is specifically for adults over 50 and individuals with certain medical conditions, such as diabetes, heart conditions, cancer, or a weakened immune system, who are at a higher risk of severe illness or hospitalization due to COVID-19.

The Efficacy of Paxlovid: Clinical Trials and Risk Reduction

Paxlovid consists of two medications: nirmatrelvir, which blocks a key enzyme needed by the COVID-19 virus to replicate, and ritonavir, which enhances the effectiveness of nirmatrelvir against the infection.

The FDA’s decision comes after extensive clinical data showed the safety and efficacy of Paxlovid in treating COVID-19.

Both Pfizer and the FDA consider Paxlovid a valuable complementary tool to vaccination, helping high-risk individuals manage COVID-19 infections and potentially saving lives.

The FDA estimated that Paxlovid could prevent thousands of hospitalizations and save lives each week in the United States.

Initially authorized for emergency use in December 2021 for high-risk individuals aged 12 and older, Paxlovid is now fully approved. The U.S. government has provided 1.1 million courses of Paxlovid for free nationwide.

Availability and Pricing: Current Supply and Future Distribution of Paxlovid

Once this supply is depleted, Pfizer will distribute Paxlovid through the commercial market at an undisclosed price. Currently, Paxlovid is priced at approximately $530 per course.

Pfizer experienced significant sales of Paxlovid in 2022, reaching nearly $19 billion, but expects a decline of 58% in revenue from the drug in 2023. The availability and uptake of Paxlovid later in the year remain uncertain.

In clinical trials, Paxlovid demonstrated significant efficacy in reducing the risk of hospitalization or death among unvaccinated high-risk adults with no prior COVID-19 infection.

Concerns and Rebound Cases: Understanding Potential Recurrence of COVID-19 Symptoms

The treatment showed an 86% risk reduction when administered within five days of symptom onset and an 89% reduction within three days.

The FDA review identified some potential drug interactions and safety concerns with Paxlovid. Immunocompromised patients, who often use immunosuppressants for HIV or organ transplant treatment, were more susceptible to adverse reactions when using Paxlovid.

The FDA recommended adjusting medication doses, increasing patient monitoring, and ensuring product labeling provides information about potential drug interactions.

One concern among doctors is the occurrence of “rebound cases” where patients experience a recurrence of COVID-19 symptoms or test positive shortly after initial recovery despite taking Paxlovid.

Reports of rebound cases emerged shortly after Paxlovid entered the market. However, the FDA review found that the overall rebound rates were similar between patients who received Paxlovid and those who received a placebo.

In conclusion, Paxlovid has received full FDA approval for treating mild to moderate COVID-19 in high-risk adults. It is seen as a valuable addition to vaccination efforts in managing COVID-19 infections among vulnerable populations.

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