‘No’ Recommendation for Aduhelm in EU; Biogen to Seek Re-exam

‘No’ Recommendation for Aduhelm in EU; Biogen to Seek Re-exam

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‘No’ Recommendation for Aduhelm in EU; Biogen to Seek Re-exam

The Committee for Medicinal Products for Human Use, or CHMP, is recommending that Aduhelm (aducanumab) should not be approved to treat the early stages of Alzheimer’s disease. The CHMP, which is part of the European Medicines Agency (EMA), voted against recommending Aduhelm last month, and now has issued its formal ruling. The decision comes despite lobbying efforts by Alzheimer’s Research UK, and the therapy’s accelerated approval in the U.S., under which Aduhelm is being marketed…

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