A controversial drug that treats the early stages of Alzheimer’s disease might become the first medication for the disease in 17 years to win regulatory approval.
Biogen Inc. said it plans to submit a regulatory filing for its aducanumab drug early next year — bringing it back into play seven months after the company appeared to abandon the drug by halting clinical trials.
“If approved, aducanumab would become the first therapy to reduce clinical decline in Alzheimer’s disease,” according to a slide from the company’s Oct. 22 earnings presentation. Biogen has said that the renewed support of aducanumab comes from a new analysis of a larger dataset of patients who were exposed to higher doses of the drug.
Approval may come down to the decisions of eight people sitting in a suburban hotel ballroom, members of an FDA advisory board known as the Peripheral and Central Nervous System Drugs Advisory Committee, according to StatNews.
Whether the FDA chooses to convene the advisory panel, and the position members subsequently take, could be telltale signs in determining if the FDA will go on to approve the drug, even though the group’s recommendations aren’t binding, StatNews reported.
Critics point to Biogen’s speedy reversal on the drug and assert that the company is misreading the results of its own clinical trials.
“Patients who received aducanumab experienced significant benefits on measure of cognition and function such as memory, orientation and language,” according to the company’s Oct. 22 statement. “Patients also experienced benefits on activities of daily living including conducting personal finances, performing household chores such as cleaning, shopping and doing laundry and independently traveling out of the home.”
- The FDA’s last Alzheimer’s drug approval was in 2003.
- The FDA amended guidelines for Alzheimer’s drug approvals last year, saying it would consider clearing treatments for early-stage medications based on cognitive benefit alone, rather than cognition and function.