COUNTING COUGHS — FDA advisers will weigh in today on whether a Merck subsidiary’s drug candidate for chronic cough produces enough benefit to patients to warrant approval. A briefing document released ahead of the meeting suggests that agency reviewers are torn over whether the effects of the tablet, known as gefapixant, are “clinically meaningful” to treat refractory or unexplained chronic cough, defined as a cough that lasts eight or more weeks. The condition is believed to affect about 5 percent of the U.S. population, according to a 2021 analysis of federal data. There was a large placebo effect in both company’s trials, FDA reviewers said, and the treatment’s small reduction of one to two coughs an hour led them to question whether it yielded “a benefit that is perceptible to patients.” Still, there’s no FDA-approved therapy for chronic cough, which can impair sleep and work productivity in patients, as well as lead to anxiety and depression. Dr. Joerg Koglin, Merck’s senior vice president for global clinical development, said the patients who participated in the drug’s late-stage trials averaged 500 coughs a day. Patients often must see multiple specialists to find the underlying cause of the cough before determining whether it’s chronic and unexplained, said Dr. Albert Rizzo, the American Lung Association’s chief medical officer. The agency denied a previous attempt by Merck to win approval for gefapixant in January 2022, citing concerns about how the company validated its cough-counting data. Merck performed a recount and analyzed it for the resubmitted application. “How much is enough for somebody who’s been suffering for a long time?” Rizzo said. The FDA is expected to make a decision by Dec. 27, Koglin said. CANCER DRUG CONFIRMATORY TRIALS SCRUTINIZED — The FDA’s independent advisers on oncological drugs met Thursday to discuss whether Acrotech Biopharma’s plan to conduct required confirmatory trials on two drugs for a type of lymphoma is sufficient to keep them on the market. The FDA granted Folotyn and Beleodaq accelerated approval in 2009 and 2014, respectively. But Acrotech’s delays in submitting a protocol for a confirmatory study mean final study results may not be available until 2030, according to meeting documents from FDA scientists and the company. To date, 12 cancer drugs that received accelerated approval and are still on the market have blown past targets for confirmatory trials, including Folotyn and Belodaq. The agency asked advisers to discuss the best ways that sponsors can meet their deadlines while conducting these confirmatory trials to avoid so-called “dangling” accelerated approvals. But the committee did not cast a vote on a recommendation. “We don’t have a direct answer for this,” said Dr. Andy Chen, a professor of medicine at Oregon Health & Science University and acting chairperson of the meeting. “We have significant concerns over the very prolonged delay in getting these confirmatory studies underway,” he said, referring to Acrotech’s two drugs. Other advisers, including Gita Thanarajasingam, a professor of medicine at the Mayo Clinic, noted that pulling the drugs from the market could leave some patients without any treatment options. But she also emphasized the need for confirmatory data and suggested looking for ways to encourage more patients and clinicians to participate. EYE DROP RECALL — The Indian manufacturer of more than 20 eye drop products for several major brands issued a voluntary recall this week, the FDA said. The agency warned consumers last month not to buy or use certain over-the-counter eye drop products after FDA investigators discovered unsanitary conditions in the manufacturing facility.
| 
