The US Food and Drug Administration today (Monday) approved the use of Biogen Inc. (BIIB.O)’s aducanumab drug as the first treatment for Alzheimer’s disease. Since the news of the approval, the company’s shares have started to jump more than 52% to $ 434.25 per share, despite the controversy over whether the clinical evidence proves the drug works.
Dr Ronald Peterson, an Alzheimer’s specialist, told Reuters that “the approval of the drug is a real good thing.” He stressed that “this is good news for patients with Alzheimer’s disease. We were never approved for treatment. “However, the doctor explained that” this is not a treatment that will completely stop the disease, but will slow it down significantly. “
Existing Alzheimer’s treatments as of 2021 are designed to alleviate the symptoms of the disease, while the new drug targets its underlying cause and aims to slow its rate of progression. The FDA said Biogen will need to conduct a post-approval trial to verify the clinical benefit of the drug. In the media and the drug will not work as planned, it will be possible to take it out of the market.
The FDA decision did not define whether the drug would be suitable only for early-stage or advanced Alzheimer’s patients – raising the possibility that the treatment population could be larger than expected.
Biogen estimates that about 1.5 million Americans will be eligible for aducanumab treatment, which will be given a monthly infusion, raising concerns about health care costs. The number of Americans living with Alzheimer’s is expected to rise to 13 million people by 2050, according to the Alzheimer’s Association.