Government health official on Monday approved Biogen’s aducanumab as the first treatment to attack a likely cause of Alzheimer’s disease, sending its shares soaring, despite controversy over whether the clinical evidence proves the drug works.
Biogen said it has priced the drug, to be sold as Aduhelm, at $56,000 per year. Its shares jumped nearly 52 percent to $434.52 when trading resumed following the approval. U.S. traded shares of partner Eisai Co were already up $33.50, or 45 percent, to $107.75
Aducanumab aims to remove sticky deposits of a protein called amyloid beta from the brains of patients in earlier stages of Alzheimer’s in order to stave off its ravages, which include memory loss and the inability to care for one’s self.
“This is good news for patients with Alzheimer’s disease. We’ve not had a disease modifying therapy approved ever,” said Dr. Ronald Petersen, an Alzheimer’s disease expert at the Mayo Clinic. However, he cautioned, “This is not a cure. It’s hoped that this will slow the progression of the disease.”
“I think this is a big day,” Peterson said. “But we can’t overpromise.”
Alzheimer’s is the sixth leading cause of death in the United States.
The Food and Drug Administration (FDA) on its website noted that trials data for the treatment was complicated with respect to clinical benefits, but added that it “has determined that there is substantial evidence that Aduhelm reduces amyloid beta plaques in the brain and that the reduction in these plaques is reasonably likely to predict important benefits to patients.”
Biogen’s drug had been hailed by patient advocates and some neurologists eager to have an effective option for patients with the lethal disease. Other doctors said clinical trial results were inconsistent and more proof was needed.