In a recent press release, Biogen noted some write-offs and other budget perturbations due to the unwillingness of Medicare to fully cover Aduhelm. We discussed what's happening with the FDA previously, and Biogen is finding they need to begin dismantling some of the infrastructure they were building to support a larger scale operation to provide Aduhelm to patients with Alzheimer's disease. This has hurt them financially, and they're looking for other ways to cut costs and placate stockholders.
But all is not lost. In Beating the Dementia Monster, we discussed another Biogen monoclonal antibody treatment called BAN2401 -- also known as lecanemab. We've also discussed it on this blog. Biogen has received fast track authorization from the FDA to continue with the phase 3 trials of lecanemab. If they go as well as earlier results promised, Biogen says “lecanemab has the opportunity to become the first anti-amyloid antibody to obtain full approval for Alzheimer’s disease in the U.S..” Some of its trial results displayed better performance than aducanumab (Aduhelm), so Biogen is quite optimistic. On the assumption that lecanemab lives up to its promise, Biogen will submit their application for full approval in early 2023. Hopefully it will not be under a cloud as with aducanumab.
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