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FDA grants approval to first antiviral oral pill for Covid-19

HQ Team

May 26, 2023: The Food and Drug Administration(FDA) has granted full approval to the antiviral pill Paxlovid for high-risk adults over 50 with mild to moderate COVID-19.

“Today’s approval demonstrates that Paxlovid has met the agency’s rigorous standards for safety and effectiveness, and that it remains an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

The approval follows the recommendation from the agency’s Antimicrobial Drugs Advisory Committee (AMDAC). The committee voted 16 to 1 based on Pfizer’s three clinical trials on Paxlovid that enrolled more than 6,000 patients across 21 countries. It said the available data supported the safety and effectiveness of PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adult

Pfizer’s EPIC-HR trial for Paxlovid reduced the risk of hospitalization or death by 86% in adults treated within five days of symptom onset, and 89% in those treated within three days of symptom onset, according to an FDA review of the company’s data.

Paxlovid was approved by the FDA in December 2021 for high-risk individuals ages 12 and up under Emergency Use Authorization. Pfizer submitted an application for full approval of the drug in June 2022, but the FDA extended its review till December. High-risk kids ages 12 and up will also continue to be eligible for the drug under the EUA, though the approval does not cover this group.

Adverse reactions concerns

Advisors agree that serious adverse reactions due to interactions between Paxlovid and other drugs are a key safety concern. The medicine boxes come with a warning and fact sheet for healthcare providers. There are fears of rebound Covid cases. That’s when patients see their Covid symptoms return or get a positive test after they initially recover.

“Prescribers should review all medications taken by the patient to assess for potential drug-drug interactions and determine if other medicines that a patient may be taking require a dose adjustment, interruption and/or additional monitoring,” according to the FDA. “Prescribers should consider the benefit of Paxlovid treatment in reducing hospitalization and death, and whether the risk of potential drug-drug interactions for an individual patient can be appropriately managed.”

The agency further stipulated that nirmatrelvir-ritonavir is not intended for use as a preventive therapy either pre- or post-exposure to COVID (i.e., patients should have symptoms and a confirmed case before use).

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