Biogen, citing insurance challenges, shutters one of its Aduhelm studies | BioPharma Dive

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Biogen, citing insurance challenges, shutters one of its Aduhelm studies | BioPharma Dive


https://www.biopharmadive.com/news/biogen-aduhelm-alzheimers-trial-icare-ad/625925/


Biogen has terminated a large study evaluating its marketed treatment for Alzheimer’s disease, a decision the company says was made in response to a recent ruling from Medicare.

Known as “ICARE AD,” the study was meant to gather years of real-world data on patients prescribed Biogen’s drug, which is sold under the brand name Aduhelm. Biogen designed ICARE AD — together with two other clinical trials, one of which is required to keep Aduhelmon the market — to generate more evidence of the drug’s effects following its controversial approval last year. With ICARE AD, the company had hoped to enroll as many as 6,000 patients across approximately 200 centers in the U.S.

But eight months after it officially began, the study had just 29 participants, according to a federal clinical trials database. Only 22 trial sites were listed on the study’s database entry.