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# FDA Reviewers Seem Positive on Paxlovid NDA
- URL: https://www.fdaweb.com/fda-reviewers-seem-positive-on-paxlovid-nda/
- Published: 2023-03-15T12:00:00.000Z
- Updated: 2026-09-14T18:19:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153987

FDA reviewers say NDA data support the efficacy of Pfizer’s Paxlovid (nirmatrelvir and ritonavir) for treating mild-to-moderate Covid-19 in adults who are at high risk for progression to severe disease. The company’s data also demonstrated that Paxlovid retained antiviral activity against the Omicron variant and major subvariants, and the drug is “considered likely to retain activity against circulating and emerging variants,” according to a [briefing document](https://www.fda.gov/media/166197/download?ref=fdaweb.com) released in advance of a 3/16 advisory committee meeting. Panel members will discuss Pfizer’s submission that would move the drug from an emergency use authorization (EUA) to a traditional approval.

On the safety side, the agency says that serious adverse reactions due to drug-drug interactions (DDIs) are the key safety concern. “Safety surveillance data under EUA indicate that many Paxlovid-eligible patients are on medications with DDIs with Paxlovid (though the most common medications with DDIs could potentially be managed by holding the drug, adjusting the dose of the drug, or increased monitoring), that the majority of Paxlovid prescribers are adult primary care practitioners (who may not be experienced in managing ritonavir DDIs), and that serious adverse reactions, including death, have been reported in association with DDIs that are included in the current EUA Fact Sheet for Healthcare Providers,” the briefing document says. “In order to safely prescribe Paxlovid, the potential for DDIs needs to be considered by all prescribers, both to take actions to manage DDIs and also to determine whether Paxlovid is an appropriate treatment choice for each individual patient when factoring in the risks of serious adverse reactions due to DDIs.”

Regarding incidences of Covid-19 rebound cases, FDA says that analyses conducted by the agency and Pfizer did not identify a clear association between Paxlovid treatment and Covid-19 rebound. “Overall, these findings indicate that in a subset of SARS-CoV-2 infections, virologic and/or symptomatic rebound may occur as part of the natural progression and resolution of Covid-19 disease, irrespective of Paxlovid treatment,” the briefing document says.