Right or wrong, the aducanumab decision could turbo-boost investor interest in neurodegeneration
If accelerated approval based on surrogate endpoints becomes a reality, risk takes on a new profile
If it turns out that the aducanumab approval ushers in an era of accelerated approvals in neurodegenerative disease, FDA’s decision may have more impact on the evaluation of risk in the troubled field than on what Biogen’s drug does for Alzheimer’s patients. The consequence could be a shot in the arm for investment in neurodegenerative diseases across the board.
The chances are low that Aduhelm aducanumab from Biogen Inc. (NASDAQ:BIIB) will revolutionize Alzheimer’s disease, given the marginal signal in clinical trials — a consensus view among investors and drug developers who spoke with BioCentury. The drug’s impact will be partly governed by pricing, access and whether other regulatory authorities follow FDA’s lead. Many patients will receive it, but whether this drug alone will put a dent in the global impact of the disease is far from certain...