Biogen Scraps Infrastructure for Aduhelm Sales in US
The decision is being made in response to a policy announced last month that Medicare would only cover the cost of Aduhelm for people with Alzheimer’s disease enrolled in select clinical trials. The decision has outraged patient advocacy groups.
“We are disappointed by the recent Medicare coverage decision for Aduhelm,” Michel Vounatsos, Biogen’s CEO, said in a press release.
Aduhelm is an antibody-based therapy designed to target amyloid plaques — irregular clumps of protein in the brain that are characteristic of Alzheimer’s and are thought to drive the disease. The therapy’s ability to remove amyloid plaques has been verified in clinical trials, but large Phase 3 studies testing whether it can slow cognitive decline in Alzheimer’s had inconsistent results.
The U.S. Food and Drug Administration (FDA) last year approved Aduhelm to treat early Alzheimer’s through the accelerated approval pathway. In essence, the FDA cleared Aduhelm for sale in the U.S. based on the early data for amyloid clearance, while requiring the medicine’s manufacturers to conduct further tests to establish its effectiveness.
Biogen is planning to launch a Phase 4 clinical trial called ENVISION to further test the therapy in people with early Alzheimer’s. The company is also running a study called EMBARK (NCT04241068), which is testing Aduhelm’s continual use in those who had received it in clinical trials.
Beyond continuing to fund these research and development activities, Biogen will now be “retaining minimal resources to manage patient access programs, including a continued free drug program for patients currently on treatment in the U.S.,” the company announced.
Biogen also recently withdrew an application seeking approval of Aduhelm in Europe after regulatory authorities indicated there is not enough data to support its approval.
Lecanemab has won breakthrough therapy and fast track designations by the FDA, and data from a Phase 2b clinical trial (NCT01767311) confirmed it can clear amyloid from the brain. Biogen and Eisai plan to complete an application seeking FDA accelerated approval by mid-year.
Lecanemab’s effect on cognitive decline in early Alzheimer’s patients is being studied in an ongoing Phase 3 study called CLARITY AD (NCT03887455). Assuming the results are positive, Biogen and Eisai expect to submit an application requesting full approval of the therapy in early 2023.
“Lecanemab has the opportunity to become the first anti-amyloid antibody to obtain full approval for Alzheimer’s disease in the U.S.,” according to Biogen.
Eisai recently began the process to seek approval of lecanemab in Japan.