Drugs

Panel Votes to Support Paxlovid NDA Approval

FDA’s Antimicrobial Drugs Advisory Committee 3/16 voted 16 to 1 that Pfizer’s Paxlovid (nirmatrelvir and ritonavir) has a favorable benefit-risk profile for treating mild-to-moderate Covid-19 in adults who are at high risk for progression to severe disease. The company’s submission is seeking to convert the product’s emergency use authorization (EUA) to a traditional approval. FDA is expected to make a final review decision in May.

An FDA briefing document released before the meeting showed reviewers backing Paxlovid’s efficacy data, which also demonstrated that Paxlovid retained antiviral activity against the Omicron variant and major subvariants. Regarding safety, the document cited serious adverse reactions due to drug-drug interactions (DDIs) as being the key concern. “Safety surveillance data under the 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).

Additionally, the agency found that data did not identify a clear association between Paxlovid treatment and Covid-19 rebound cases. Some panel members recommended that Pfizer continue to study and monitor for Paxlovid-associated DDIs and Covid rebound cases.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome