The European Medicines Agency on 14 November said that Eisai/Biogen’s early Alzheimer’s disease drug, Leqembi (lecanemab), should be approved for marketing across the EU, having previously rejected the disease modifying treatment which is already approved in the US, Japan and other countries.
Leqembi Secures EMA Thumbs Up For Narrower Indication
After an initial rejection, the European Medicines Agency now says that Eisai/Biogen’s Alzheimer’s disease drug should be approved, albeit for a restricted population and with a recommendation for ongoing safety scans.

More from Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Vimkunya, Bavarian Nordic's chikungunya vaccine.
Levodopa/carbidopa (ND0612), Mitsubishi Tanabe Pharma’s investigational drug-device combination therapy for the treatment of motor fluctuations in people with Parkinson’s disease, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Japan recommends eight new drugs for approval, including two for cardiomyopathy, and will also raise prices for multiple products, including Enhertu, on 1 April.
Unofficial January results showed the US FDA continued to issue full and tentative ANDA approvals in line with previous months, but recent layoffs may not help the agency maintain that pace.
More from Drug Safety
A new EU public-private initiative is developing tools to help clarify when mini- and micropig models can be used as viable alternatives to non-human primates in non-clinical drug safety testing.
The US FDA is expected to refine warnings recently added to CAR-T cell therapies about the risk of secondary malignancies after reassuring new data, which is a positive sign for the future of the therapies in autoimmune disorders.
The Risk Evaluation and Mitigation Strategy hindered access and burdened the health care system even though it was never fully implemented or enforced. The FDA still recommends prescribers monitor patients’ absolute neutrophil count to prevent severe neutropenia.