The FDA has declined to accelerate approval of Eli Lilly’s highly anticipated Alzheimer’s drug, but the reason for the rejection may presage a forthcoming thumbs-up.
That’s because the investigational drug, donanemab, cleared amyloid plaques so efficiently in its Phase 2 trial that too many patients were pulled out of treatment halfway through FDA’s stipulated 12-month trial window for at least 100 participants.
Lilly announced the development Jan. 19, saying FDA named no other shortcomings in Lilly’s application for accelerated approval.
The company said its Phase 3 trial, already underway, is unaffected by the decision. Lilly expects key Phase 3 data in the spring or summer and will aim those results at winning a standard or conventionally expedited approval.
The Phase 3 trial will be watched closely for efficacy, as donanemab’s overall positive safety profile was initially documented in May 2021 in the New England Journal of Medicine and has “remained consistent since our accelerated approval submission,” Lilly states in this week’s announcement.
Count the consumer group UsAgainstAlzheimer’s among the stakeholder organizations anxiously awaiting FDA’s final decision on donanemab.
In a statement posted fast on the heels of Lilly’s announcement, the group’s chief operating officer, Russ Paulsen, says UsAgainstAlzheimer’s is “disappointed this treatment won’t be made available to patients sooner.”
However, Paulsen adds, the group is “very encouraged” by the reason many patients were unable to complete donanemab’s Phase 2 regimen.
“[W]e look forward to learning even more about donanemab’s effectiveness when Lilly releases its Phase 3 trial data later this year in advance of its application for traditional FDA approval,” Paulsen says.
Alzheimer’s care advocates hope at least one clear winner emerges from among donanemab and two other amyloid busters raising hopes in recent months—lecanemab and the controversial aducanumab, both developed by Eisai and Biogen.
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.