Remember aducanumab?
Not long ago, the fate of Biogen’s long-debated treatment for Alzheimer’s disease looked like the odds-on biggest biotech story of 2020. Various things transpired since then, but yesterday the company gave the world a timetable on the future of the oft-delayed aducanumab.
Biogen finally filed its controversial treatment for FDA approval, checking a box that has little importance in itself but sets in motion a series of events. Next, the FDA has 60 days to either accept or reject Biogen’s filing. Then, it will decide whether to give aducanumab a six- or 10-month review. Some time in between, the agency will almost certainly convene a panel of outside experts to debate the merits of the drug.
And those merits, as you might recall, are complicated. In one Phase 3 trial, Biogen’s treatment met its goal of slowing cognitive decline. In a second, it failed. Both studies were terminated early because they appeared hopeless. Months later, Biogen emerged with a take that, if you look at all of the data, aducanumab worked for those who got the highest dose for the longest period of time. At last, we’re going to find out whether the FDA agrees.
Biogen finally filed its controversial treatment for FDA approval, checking a box that has little importance in itself but sets in motion a series of events. Next, the FDA has 60 days to either accept or reject Biogen’s filing. Then, it will decide whether to give aducanumab a six- or 10-month review. Some time in between, the agency will almost certainly convene a panel of outside experts to debate the merits of the drug.
And those merits, as you might recall, are complicated. In one Phase 3 trial, Biogen’s treatment met its goal of slowing cognitive decline. In a second, it failed. Both studies were terminated early because they appeared hopeless. Months later, Biogen emerged with a take that, if you look at all of the data, aducanumab worked for those who got the highest dose for the longest period of time. At last, we’re going to find out whether the FDA agrees.
.png)
No hay comentarios:
Publicar un comentario