Drugs

2nd CRL for Merck’s Gefapixant Chronic Cough Drug

FDA has issued a complete response letter saying that Merck’s NDA resubmission for gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, did not meet substantial evidence of effectiveness for treating refractory chronic cough and unexplained chronic cough. A company statement says the letter was not related to gefapixant safety.

An earlier NDA was issued an FDA complete response letter in 1/2022. The resubmission included additional analyses and information related to the cough counting system that was used to assess efficacy. The company says it is reviewing the agency’s feedback to determine the next steps.

Late last year, FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 12 to 1 that the evidence does not demonstrate that gefapixant provides a clinically meaningful benefit. The panel was convened after agency reviewers concluded that making an assessment on the clinical meaning of “complicated” data presentations in the Merck NDA resubmission for chronic cough medicine gefapixant is a challenge and expert input was needed (see earlier story).

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