U.S. regulators have approved Biogen Inc’s aducanumab as the first treatment to attack a likely cause of Alzheimer’s despite controversy over whether the clinical evidence proved the drug works, sending its shares soaring.
Biogen said, “It has priced the drug, to be as Aduhelm, at $ 56,000 or about 40 lakh per year. After jumping more than 50%, Biogen shares closed up 38.3% at $395.85 their highest closing level in over six years. The U.S. traded shares of Japanese partner Eisai Co rose 56% to 116.03.
Aducanumab works by removing strictly 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 oneself.
“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 cautions, “This is not clear. It’s hoped that will slow the progression of the disease.” Alzheimer’s is the sixth-leading cause of death in the United States.
The Food and Drug Administration on its website results from clinical trials of Aduhelm were mixed, but the drug was shown to reduce amyloid-beta plaques in the brain, which is likely to benefits patients.
“We decided that the accelerated approval pathway fits well here, “Dr Patrizia Cavazzoni, director of the FDA’s allows for there being some residual uncertainty on the drug’s clinical benefits while making the drug available to patients rather than having to wait.”
Under that pathway, BIogen is required to conduct a confirmatory clinical trial, but have several years to do so, she said.
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.
“I’m surprised and disappointed,” said Dr Caleb Alexander, A drug researcher at Johns Hopkins who was on the FDA’s Advisory that voted against approval of Biogen’s drug.