The U.S. Food and Drug Administration (FDA) has granted a landmark approval for a new drug to treat Alzheimer’s, a neurologic disorder that affects millions worldwide. It’s the first medication cleared by US regulators to treat the ailment in two decades.

• The drug granted clearance is Aduhelm made by Cambridge-based Biogen. It’s a branded name for Aducanumab, a medication that works by removing sticky deposits of a protein called amyloid beta found in the brains of early Alzheimer’s patients, with the hopes of reducing the ailment’s buildup.

• As a note, Aduhelm is not a cure for Alzheimer’s, but a way to attack what is believed to be an underlying cause in the disease in its early stages. It can’t be used to tackle Alzheimer’s that has already progressed to later stages.

• Aduhelm will cost $56k per year to patients. 

• The FDA clearance for Aduhelm came despite objections from many in the scientific and medical community, where there has been a fierce debate on the evidence of it slowing down cognitive decline in Alzheimer’s patients. Even, the FDA’s independent advisory committee largely voted against recommending approval for the drug last year.

• While there’s been skepticism in the scientific and medical communities, there’s been rejoicing in the world of business and stonks. During trading on Monday, Biogen shares surged more than 60% at one point, before cooling down to end the day 38% higher.

• The 38% surge represented about $16bn added to Biogen’s market cap, which now stands at nearly $60bn. With a $56k per year price tag and millions of potential patients to treat, it’s not surprising that investors reacted so positively to the FDA’s clearance of Biogen’s Alzheimer’s drug.

• Biogen’s Aduhelm was granted a Fast Track designation by the FDA. That’s a process designed to speed up the review and development of a drug showing potential to fill an unmet medical need, Alzheimer’s in this case.

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