Biogen’s historic Alzheimer’s drug gets US approval

Drug is the first to target the cause of Alzheimer’s disease rather than easing symptoms

Biogen’s new drug for Alzheimer’s disease has won approval from US regulators, making it the first of its kind to be approved in the US in nearly 20 years.

The US Food and Drug Administration (FDA) said that it has approved Biogen’s drug, which goes under the brand name Aduhelm, using its Accelerated Approval (AA) pathway. The AA protocol aims to provide earlier access to valuable therapies for patients with serious diseases.

Alzheimer’s, which is the most common cause of dementia, gradually destroys memory and cognitive skills.

The new drug is the first to target the cause of the disease – existing treatments for Alzheimer’s only help to ease the symptoms. 

“Uncertainty” over clinical benefit

The FDA explained that its fast-tracking of the drug came because “there was an unmet need, and ... an expectation of clinical benefit despite some residual uncertainty regarding that benefit”. 

A common marker for patients with Alzheimer’s is the build-up of amyloid beta plaques in the brain. The FDA said that clinical trials for Aduhelm were the first to show that a reduction in amyloid plaques could be “expected to lead to a reduction in the clinical decline of this devastating form of dementia”.

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FDA monitoring 

The FDA went on to add that although the Aduhelm data is “complicated” with respect to its clinical benefits, there is “substantial evidence” that the new drug reduces amyloid beta plaques in the brain, which should offer important benefits to patients.  

The FDA will continue to monitor the drug after its launch and requires Biogen to conduct a post-approval clinical trial to verify the presumed benefits of the drug. If Aduhelm does not work as intended, the FDA can remove it from the market.

At the same time, Biogen CEO Michel Vounatsos said that Biogen is also investing in the development of more than 30 clinical programme, including additional possible treatments for Alzheimer’s disease, as well as other neurological conditions, such as Parkinson’s disease, ALS (motor neurone disease) and stroke. 

Biogen, which has spent more than $28bn in research and development since 2003, says that 1.5 million Americans would be eligible for the new Alzheimer’s drug, which is administered via infusion.

Further reading: Pfizer-BioNTech vaccine approved for 12-15 year olds by UK regulator

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