(Reuters) – Biogen Inc and partner Eisai Co Ltd said on Wednesday they were working to speed up completion of a confirmatory trial of their controversial Alzheimer’s drug that was recently given an accelerated approval by the U.S. drug regulator.
The U.S. Food and Drug Administration approved the drug on June 7 using its accelerated approval pathway, which requires a study to confirm the drug works as intended, and gave a deadline of nine years ending 2029 for the trial.
The drug, Aduhelm, has faced criticism over pricing and whether or not the clinical data were strong enough to support the approval.
The FDA approved the drug – despite strong objection of its own expert advisory panel – for all patients with Alzheimer’s, although Aduhelm has only been tested for patients in the early stages of the disease.
On Tuesday, the FDA defended its decision to approve the drug and told Reuters it was working with the drugmakers to accelerate the completion of the study.
Biogen and its partner said they were engaging with U.S. Centers for Medicare & Medicaid Services (CMS) to help provide patients across a spectrum of financial situations access to the drug.
The companies have set an average price of $56,000 a year for the drug. They said they do not plan to raise the price for four years following launch and are ready to work with payers, including CMS, to create agreements that could lower out-of-pocket expense for patients treated with Aduhelm.
The drugmakers estimate only 10% of Medicare patients may have to pay 20% of the out-of-pocket costs, with 40% patients estimated to have exposure of approximately $200 or less a year, and the remaining 50% will have a cap on out-of-pocket expenses.
(Reporting by Mrinalika Roy in Bengaluru; Editing by Shinjini Ganguli)