FDA approves first Alzheimer’s treatment since 2003 in controversial decision

The FDA on Monday granted approval for the first new Alzheimer’s treatment since 2003, drawing mixed reactions amid opposition from some experts and an independent advisory committee.

A top FDA official said the agency decided to use the “accelerated approval” process for Biogen’s drug aducanumab to provide for patients enduring “serious diseases where there is an unmet need” and an expectation that the treatment will benefit patients.

The agency called the demand for treatments “urgent” as Alzheimer’s affects more than 6 million Americans and is the sixth leading cause of death in the U.S.

“In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in the statement.

Background: Two earlier clinical trials for the drug, also known by the brand name Aduhelm, examined by the FDA produced conflicting results on whether the drug slows cognitive decline.

These trial results prompted the independent Peripheral and Central Nervous System Drugs Advisory Committee to overwhelmingly recommend in November for the FDA to reject Biogen’s drug. But the FDA strayed from the committee’s advice with its Monday approval.

What’s next: With the accelerated approval, Biogen will be required to conduct another trial to prove the clinical benefit of its drug. The FDA could take steps to remove the drug from the market if the benefit is not proven.

“We believe that the data supports accelerated approval, while holding the company accountable for conducting an additional study to confirm the benefits observed in one of the trials, which we fully intend to do,” Cavazzoni told reporters on a press call Monday.