Regardless of the Facilities for Medicare & Medicaid Providers’ (CMS) determination on April 7 to severely limit coverage of Biogen’s (NASDAQ:BIIB) Aduhelm (aducanumab) for Alzheimer’s illness, different drugmakers are forging forward with their candidates for the situation.
On Friday, Eisai (OTCPK:ESALY) mentioned it expects to finish a rolling submission for a Biologics License Application (BLA) for lecanemab to the U.S. FDA below the accelerated approval pathway in Q1 fiscal 2022 (started April 1, 2022).
Eli Lilly (NYSE:LLY) is creating donanemab and in addition mentioned Friday it’s urgent forward with its rolling utility, which it expects to finish by the tip of the yr, Reuters reported. Nevertheless, the drugmaker will not have section 3 information obtainable till mid-2023.
Roche (OTCQX:RHHBY) is anticipated to launch late-stage information on its candidate, gantenerumab, by the tip of the yr, although it isn’t pursuing accelerated approval.
The CMS determination covers FDA-approved monoclonal antibodies that focus on amyloid protein utilizing its discount from the mind as a surrogate endpoint that’s “fairly prone to predict medical profit,” however solely in medical trials.
That would depart Eisai (OTCPK:ESALF), Lilly (LLY), and Roche (OTCQX:RHHBY), like Biogen (BIIB) with Aduhelm, in precarious positions contemplating their candidates additionally goal amyloid plaque discount below the idea that eradicating amyloid slows cognitive decline. The issue is that researchers nonetheless aren’t sure that that is the case.
One potential brilliant spot within the CMS determination is that the company mentioned it might cowl authorised antibodies primarily based on direct medical profit — equivalent to proof of slowing cognitive decline — in CMS-approved potential comparative research. Though the efficacy bar is considerably greater, this might profit drugmakers as CMS famous examine designs for these trials are much less rigorous.
Such a examine may embrace information generated from routine medical observe or a registry. “Registry information might then be used to evaluate whether or not outcomes seen in rigorously managed medical trials are reproduced in real-world use and in a broader vary of affected person teams,” CMS wrote.
That would finally open the door to broader protection determinations for different Alzheimer’s medicine, and income from them to drugmakers. However to ensure that this to occur, pharmaceutical firms must present their medicine result in a significant slowing down of cognitive decline, one thing no therapy has but to obviously exhibit.