The federal Food and Drug Administration has created an instant medical and regulatory morass by giving an accelerated approval to Biogen’s costly prescription medication targeted at patients with Alzheimer’s disease.
This is the first drug to win the precious official nod from the FDA in almost two decades.
But the agency’s OK to market aducanumab (pronounced “add-yoo-CAN-yoo-mab”), which will go by the brand name Aduhelm, may go in the books as one of the sketchiest and most ferociously contested in recent times. The drug somehow overcame Everest-sized reasons why, at best, it needed further study — which it is supposed to get. And it faces Himalayan-sized criticisms that it will raise false hopes for those afflicted with a condition that is spiking in a fast-graying nation, and for which no effective medical remedy has been found.