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If approved, aducanumab will still have hills to climb

Even if FDA approves Biogen’s aducanumab, reimbursement and care infrastructure challenges await

As doctors digest Biogen’s aducanumab data, the possible approval of the first disease-modifying therapy for Alzheimer’s disease is raising questions around reimbursement and how to build the necessary infrastructure among physicians and hospitals.

While investors rewarded Biogen Inc. (NASDAQ:BIIB) for its late but welcome Phase III data, adding nearly $11 billion to its market cap, doctors are still making sense of the discordant results and how they might use aducanumab if it is approved (see “Biogen’s Aducanumab Pleases Investors, Confounds Doctors”).

The data, announced Oct. 22, showed the anti-β amyloid mAb met the primary endpoint and secondary endpoints in one of two trials, making it the first amyloid lowering agent to score a Phase III win. Biogen had stopped both trials in March after they failed a pooled interim futility analysis.

The main sticking point is how one trial, EMERGE, could be so clearly positive, showing a dose response between the low- and high-dose groups across all cognitive and pathological endpoints, while the other, ENGAGE, showed nearly the opposite, with the high dose performing worse or similar to the low dose across the same endpoints (see “Aducanumab Phase III Data”).

Biogen has ascribed the conflicting findings to a protocol change and conducted a post hoc analysis of ENGAGE to support this hypothesis. The biotech plans to submit a BLA for aducanumab in early 2020 based on its discussions with FDA.

“Whether we need another trial to make a regulatory decision is up to regulators, but from a scientific point of view, we need another trial.”

Howard Fillit, Alzheimer’s Drug Discovery Foundation

FDA and EMA have frequently required positive data from two controlled trials to support approval of agents to treat neurological conditions, suggesting FDA could ask Biogen to run another trial.

However, the agency might consider accelerated or conditional

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