STAT+: Pharmalittle: FDA advisers vote overwhelmingly against ALS treatment; weight-loss drugs scrutinized over reports of suicidal thoughts
A FDA advisory panel voted overwhelmingly against a polarizing potential treatment for ALS, concluding that supporting data were inadequate.
Top of the morning to you, and a fine one it is. Despite overcast skies, we are enjoying the hustle-bustle of passing cars, barking dogs, and other signs of life as we rev up for another day. The coffee kettle is firing up — maple bourbon is our choice cup of stimulation — and the backing soundtrack is in order. So time to get cracking. Toward that end, we have assembled the latest laundry list of interesting items for you to peruse. As for us, we have items to write and calls to make. So best of luck on your journey and, as always, do keep in touch. …
A U.S. Food and Drug Administration advisory panel voted overwhelmingly against a polarizing potential treatment for ALS, concluding that supporting data did not meet the standard for approval, STAT reports. After a day-long meeting that included impassioned testimony from ALS patients, the panel voted 17-1 with one abstention that the case for NurOwn, a treatment from BrainStorm Cell Therapeutics, was based too heavily on convoluted clinical trial results and compelling but unreliable anecdotal evidence. The treatment is the latest flashpoint in a societal debate over how to balance the needs of patients with grave diseases against the traditional standards of reviewing new medicines.
The FDA received more than 250 reports of patients experiencing suicidal thoughts or behaviors while taking Ozempic or similar medicines since 2010, Reuters reports, citing an examination of the FDA adverse-event database. Thirty-six of these reports describe a death by suicide or suspected suicide. Accounts of suicidal thoughts linked to this class of drugs, called GLP-1 receptor agonists, are drawing increasing scrutiny, including an investigation by European regulators announced in July. In a statement to Reuters, the FDA said it is evaluating such reports and will decide on what action, if any, to take after a thorough review.
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