Biogen’s (NASDAQ:BIIB) aducanumab is more likely to be granted conditional versus full FDA approval in Alzheimer’s disease (AD) based on recent presented data, investigators said. The results presented in the Phase III EMERGE study need confirmation in order for the drug to not face a regulatory thumbs down, they said.
Still, an expected advisory committee (AdCom) meeting vote will be split, and it is unlikely that the panel will be unanimous in their recommendations for aducanumab given the current data, the investigators said. Despite this caveat, high unmet needs in AD and patient advocacy group support would mean a rejection inviting much criticism for the FDA, creating an incentive for the agency to consider the conditional approval option, they said.
The highly anticipated data for the 1,638-patient EMERGE (NCT02484547) study at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting on 4–7 December in San Diego, California revealed that aducanumab achieved a modest effect comparable to some currently used AD treatments, meeting benchmarks the investigators had previously said would be approvable. However, gaps in the data make a straightforward, nonconditional approval unlikely, investigators said. But rejection is less likely considering patient support and that Biogen’s CTAD presentation strengthened impressions of EMERGE and adequately explained why the 1,647-patient ENGAGE (NCT02477800) Phase III trial in AD failed, they said.