(Bloomberg) -- Biogen Inc. will begin screening patients in May for a four-year study aimed at confirming the effectiveness of Aduhelm, the company's controversial Alzheimer's medicine.
The drugmaker submitted a final protocol for the global trial to the U.S. Food and Drug Administration and intends to enroll about 1,500 patients, according to a statement Wednesday.
Both Biogen and the FDA have been under fire since the regulator gave accelerated approval to Aduhelm despite conflicting results from studies and objections from outside agency advisers. U.S. health officials later issued a preliminary decision that drugs like Aduhelm will only be paid for when patients are enrolled in approved clinical trials, and the drug's use has been a fraction of what analysts had initially expected.
Biogen reaffirmed its goal of recruiting at least 18% of U.S. patients in the trial from Black and Latino communities.
“Our unwavering commitment is to ensure that the trial is completed swiftly and that the diversity of patients in it reflects that of Americans diagnosed with early Alzheimer's disease,” Samantha Budd Haeberlein, head of neurodegeneration development, said in the statement.
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