The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for donanemab (Eli Lilly), an investigational anti–beta amyloid therapy for Alzheimer’s disease (AD), the company announced Thursday.
Eisai/Biogen also announced that it has received breakthrough therapy designation for its anti–beta amyloid agent lecanemab (formerly BAN2401), as reported by Medscape Medical News.
Earlier this month — amid significant controversy — the FDA granted accelerated approval to aducanumab (Aduhelm), the first antiamyloid agent for the treatment AD.
In a statement, Maria C. Carrillo, PhD, chief science officer for the Alzheimer’s Association, said these FDA actions are “exciting advances” in the Alzheimer’s treatment pipeline that “underscore the scientific validity of pursuing this treatment pathway.
“We know that history shows FDA action leads to greater investment and innovation, and the discovery and development of more and better drugs. This is already happening. While these new announcements are encouraging, we need to continue to diversify the Alzheimer’s treatment pipeline,” said Carrillo.
The breakthrough therapy designation for donanemab is based on data from the phase 2 TRAILBLAZER-ALZ study, which met the primary outcome of slowing cognitive decline for patients with early symptomatic AD, as previously reported by Medscape Medical News.
Results from the TRAILBLAZER-ALZ trial were presented at the virtual 2021 International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD) and were simultaneously published online March 13 in The New England Journal of Medicine.
Lilly said it plans to submit a biologics license application for donanemab under the accelerated approval pathway later this year. The application will be based on data from TRAILBLAZER-ALZ.
The safety, tolerability, and efficacy of donanemab are being evaluated in the ongoing phase 3 TRAILBLAZER-ALZ 2 study.
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