Aducanumab Review: Looking For Precedents – Long Ago And Far Afield
The run-away US FDA advisory committee review of Biogen’s Alzheimer’s candidate was highly unusual. But like most things at the agency, not entirely unprecedented.
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US FDA’s plan to reconvene an advisory committee for a second look at Amylyx’ ALS drug AMX0035 is a remarkable twist in the ongoing review. It is essentially unprecedented, though there are two examples from the 1990s that offer some parallels.
The aducanumab review involved everything sponsors might think they could want from the US FDA, with the agency taking a hands on approach to expedite a complex and difficult review in hopes of delivering an important new therapy to patients as quickly as possible. Unfortunately, in this case, FDA seems to have expedited the review right over a cliff.
FDA grants approval to two of three indications for gram-negative antibiotic based on Phase II data but follows its advisors in rejecting a third indication that came without human data, offering hints of what the limitations and possibilities of a formal limited population antibiotic approval pathway might look like.