Drugs

Merck NDA for Cough Drug Accepted for Review

FDA has accepted for review a Merck NDA for gefapixant, an investigational selective P2X3 receptor antagonist for treating refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. An RCC is a cough that persists despite appropriate treatment of underlying conditions, and a UCC is a cough where the underlying cause cannot be identified despite a thorough evaluation. The agency has set a user fee review action target date of 12/21.

The submission is based on data from the COUGH-1 and COUGH-2 clinical trials that involved 2,044 patients. The primary efficacy outcomes measure for COUGH-1 and COUGH-2 were 24-hour cough frequency at week 12 and 24-hour cough frequency at week 24, respectively, measured using an ambulatory digital audio recording device, according to the company. In these studies, adult patients treated with gefapixant 45 mg twice daily demonstrated a “statistically significant reduction” in 24-hour cough frequency versus placebo at 12 weeks (18.45% reduction relative to placebo). At 24 weeks, data showed a 14.64% reduction relative to placebo, the company says. The gefapixant 15 mg twice daily treatment arms did not meet the primary efficacy endpoint in either Phase 3 study.

Gefapixant is described by Merck as a selective P2X3 receptor antagonist. P2X3 receptors are one of the receptor types found on sensory nerve fibers, predominantly C fibers, in the airway lining. “Chemical stimuli, including adenosine triphosphate (ATP), can be released from airway lining cells due to airway inflammation, irritation and mechanical stress/injury,” the company says. “The inhibition of binding of extracellular ATP to P2X3 receptors is thought to reduce sensory nerve activation and, subsequently, cough.”

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