The drug will leave the market in November 2024.
Data suggested it could possibly slow cognitive decline slightly, but it couldnt cure Alzheimers.
Accelerated approval requires a post-approval clinical trial to prove effectiveness, which Biogen is also ending.
Photo Illustration by Michela Buttignol for Verywell Health; Getty Images
Why Is Aduhelm Being Discontinued?
Whats Next for Alzheimers Patients?
Leqembi is a monoclonal antibody requiring twice-a-month infusions, though an injectable version is in the works.
Just like Aduhelm, Leqembi is indicated for patients with mild cognitive impairment or early stages of Alzheimers disease.
But Leqembi may be only minimally safer and more effective than Aduhelm.
Leqembi was originally grantedaccelerated approvallast yearbut received full FDA approvala few months later.
Thats got to be a decision made in conjunction between the patient and their clinician, Gordon told Verywell.
Despite Aduhelms shortcomings, the Alzheimers Association credits the drug with generating interest and advancement in Alzheimers drug research.
More drugs are in the pipeline for the condition; aLilly medication called donanemabis under FDA review now.
What This Means For You
Aduhelm paved the way for innovation in Alzheimers treatment.
Food and Drug Administration.FDA grants accelerated approval for Alzheimers drug.
Alzheimer’s News Today.Alzheimers Association welcomes Aduhelm price cut, but presses on.
