In this underserved market, anti-Aβ MAbs lecanemab and donanemab are poised to follow on the heels of the U.S. FDA’s landmark accelerated approval of ADUHELM for the treatment of Alzheimer’s disease (AD). Lecanemab and donanemab could offer differentiated clinical profiles, which may be bolstered by phase 3 results that are expected to be reported beginning in late 2022.
Clinical trial data suggest that sufficient exposure to optimal doses of anti-Aβ MAb therapy could be clinically effective in early AD. Phase 3 trial results, expected before a confirmatory post-marketing trial of ADUHELM is complete, could further validate — or refute — the efficacy of agents in the class.
2022: United States
2025: Europe and Japan
Patents estimated to expire beginning in 2031
How will donanemab impact the market for Alzheimer’s disease?
What gaps in treatment does donanemab fill?
The most critical need for patients has long been safe, effective DMTs that slow cognitive and functional decline. Initial uptake of ADUHELM has been slow for a multitude of reasons, limiting the patient benefit. Donanemab could offer improved risk/benefit profiles over ADUHELM, and additional therapies could eventually provide greater patient choice and potentially greater affordability.
What hurdles might it need to overcome to reach blockbuster status?
While blockbuster sales should easily be reached based on population size, market demand and pricing, questions remain amid ongoing controversy about ADUHELM’s approval, pending payer decisions and data readouts. Slow uptake is likely until more data are released and reimbursement clarity is achieved.
“They seem extremely interesting. Since this is still a phase 2 study, we need a large trial to understand this new molecule’s efficacy. We are talking about drugs that are very tricky to manage. Before being enthusiastic, I would like to have results that give me the opportunity to offer this kind of treatment to my patients.”
– Source: Cortellis Competitive Intelligence, Drug Timeline & Success Rate prediction current as of December 15, 2021