FDA Narrows Label To Recommend Use Of Biogen's Aduhelm In Mild Alzheimer's Patients

Biogen Inc. BIIB shares are lower after the company announced an updated label for its recently-approved Alzheimer's treatment Aduhelm.

What Happened: Biogen, which is partnering with Japan's Eisai Co., Ltd. ESALY for Aduhelm, said the Food and Drug Administration updated the label for the treatment to emphasize the disease stages studied in the clinical trial.

"Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials," the updated label suggests.

The FDA further clarified there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. Clinicians and the scientific community had previously slammed the regulator for issuing a broader label for Aduhelm.

Biogen said the update was based on its ongoing conversations with prescribing physicians, FDA and patient advocates and its subsequent submission to the FDA the label update.

"We are committed to continue to listen to the community's needs as clinical practice adapts to this important, first-in-class treatment option," said Alfred Sandrock, Jr, Head of R&D at Biogen.

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Why It's Important: The House Committee on Oversight and Reform said last month it will investigate the controversial approval and pricing of Aduhelm. Democrats have also called upon the U.S. Department of Health and Human Service to look into FDA's dealings with the Biogen that culminated in the approval of the treatment.

The list price of Aduhelm is being set at $56,000 per year.

For Biogen, a smooth launch and success in the post-approval confirmatory trial are keys for realizing benefits out of years of research into the area.

Sell-side, though surprised at the ease with which the approval came about and the broader label, sees the approval as a "narrative change" for the company.