Biogen pulls plug on Aduhelm real-world study on coverage woes
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Biogen's (NASDAQ:BIIB) Alzheimer's disease therapy Aduhelm woes seem to continue as the company terminated a study called ICARE AD, which was started to collect real-world data on the drug's use in the U.S.
The decision comes on the back of limited coverage of Aduhelm (aducanumab) in the U.S. In April, the U.S. Centers for Medicare & Medicaid Services (CMS) officially limited the coverage on the drug.
"As a result of the national policy for coverage, it is expected there will be limited aducanumab-avwa prescription and usage in routine clinical practice making the study not feasible for enrollment," Biogen said on ClinicalTrials.gov.
Biogen had planned to enroll ~6K people in the trial but since Nov. 18, 2021 â when the study started â only 29 patients could be enrolled.
Biogen, however, has set up a continuity of care plan to provide the drug at no cost for the treatment duration to those who started therapy before April 7, Fierce Pharma reported.
Biogen and Japan's Eisai (OTCPK:ESALY) (OTCPK:ESALF) had developed and commercialized Aduhelm together but in March the two companies amended their collaboration on the drug.
Biogen had also withdrawn its EU marketing application for the drug citing the inadequacy of data.
Biogen had laid off more than 100 workers â a vast majority in its Alzheimer's division â as a result of the commercial failure of the Alzheimer's therapy.