STAT+: Pharmalittle: FDA panel backs conditional approval for Biogen ALS drug; pharma fights tactic for lowering specialty med costs
A FDA advisory panel concluded that a Biogen treatment for a rare, genetic form of ALS should be conditionally approved, despite unanswered questions.
Rise and shine, everyone, another busy day is on the way. This morning is getting off to a fabulous start, though, as a delightfully warm sun is enveloping the subdued Pharmalot campus, where the official mascot is happily snoozing and the sounds of spring can be heard from our window. As always, we are quaffing some cups of stimulation — roasted coconut is our choice du jour — and assembling some tidbits for your pleasure. So, time to get cracking. Hope you have a smashing day, and do stay in touch. We always enjoy your tips and insights. …
A U.S. Food and Drug Administration advisory panel concluded that a treatment developed by Biogen for a rare, genetic form of ALS should be approved, despite unanswered questions about its benefit to patients, STAT reports. The panel voted 9-0 that the “totality of the evidence” was sufficient to support conditional approval of the Biogen drug, called tofersen. By a 5-3 vote (with one abstention) the panel concluded the tofersen data, including from a failed clinical trial, were not sufficiently convincing to support full approval. The mixed votes suggest the FDA will likely grant accelerated approval, which would allow Biogen to market the drug while it collects additional data to confirm its benefit.
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