FDA Approves First New Alzheimer’s Drug In Almost 20 Years

The Food and Drug Administration (FDA) on Monday granted approval for the first new Alzheimer’s treatment since 2003.

The decision comes as the debate over whether to approve Biogen’s drug aducanumab has stirred controversy, with some Alzheimer’s experts and an independent advisory committee opposing approval saying there’s not enough evidence that the drug is effective.

In a statement, a top FDA official on Monday said it decided to use an “accelerated approval” process to make drugs and therapies available to patients enduring “serious diseases where there is an unmet need” and “an expectation of clinical benefit.”

Aducanumab, also known by the brand name Aduhelm, is considered the first treatment to register progress in removing protein deposits called amyloid beta plaques in the brain at the onset of Alzheimer’s, slowing cognitive decline.

The FDA usually follows its advisory committees’ recommendations, but this time it strayed from the Peripheral and Central Nervous System Drugs Advisory Committee’s recommendation in November to overwhelmingly reject Biogen’s drug.

Read more at The Hill.

{Matzav.com}