Biogen withdraws marketing application of Alzheimer’s drug Aduhelm from EU
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Biogen withdraws marketing application of Alzheimer’s drug Aduhelm from EU
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Biogen withdraws marketing application of Alzheimer’s drug Aduhelm from EU
The woes of Biogen’s Alzheimer’s drug Aduhelm continue. Recently, Biogen has decided to withdraw the Marketing Authorization Application (MAA) submitted in Europe.
At an expert meeting held recently, the European Committee for Medicinal Products for Human Use (CHMP) told Biogen that the clinical efficacy data provided by the company for Aduhelm (aducanumab) were insufficient to support its potential approval.
In December, the CHMP voted unequivocally against regulatory authorization for the controversial Alzheimer’s drug.
The regulatory opinion issued by the CHMP shares many similarities with the previous review by the FDA advisory committee that approved the drug last June.
Although the efficacy data has been questioned by many experts, Aduhelm still has the green light under the US FDA’s accelerated approval program, becoming the first Alzheimer’s disease drug approved in the US market in 18 years.
Since Aduhelm was approved in the United States, Biogen has been plagued by multiple problems, failing to meet commercial expectations, drug safety issues have also been questioned, and some patients have even died after receiving Aduhelm treatment.
Early in the clinical development of Aduhelm, researchers observed cases of amyloid-associated imaging abnormalities (ARIA-E) in some patients. [Related reading: 3 more patients died! Biogen’s Alzheimer’s drug Aduhelm continues to be controversial]
Just earlier this month, the U.S. Centers for Medicare and Medicaid Services (CMS) formally decided to strictly limit coverage for Biogen’s controversial Alzheimer’s drug Aduhelm to patients participating in clinical trials only. . However, Biogen has not given up its research and development work on Alzheimer’s disease.
After Aduhelm, Eisai and Biogen are currently actively developing lecanemab. The companies previously announced that Eisai will lead the development and regulatory submission of lecanemab globally, and that both parties will be jointly responsible for the future commercialization and promotion of the therapy.
Reference:
Biogen Gives Up on EU Approval of Aduhelm Following CHMP Opinion
Biogen withdraws marketing application of Alzheimer’s drug Aduhelm from EU
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