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EMA Approves Leqembi for Early-Stage Alzheimer's with Enhanced Monitoring

• The European Medicines Agency (EMA) has granted approval for Leqembi, an Alzheimer's disease drug developed by Eisai and Biogen, for use within the EU. • Leqembi's approval is specifically indicated for patients in the early stages of Alzheimer's, requiring initial screening for genetic factors and ongoing safety monitoring. • This decision follows an initial rejection, with the EMA now recommending the drug's use under stricter guidelines to ensure patient safety and efficacy. • The approval marks a significant step forward in addressing Alzheimer's, though with a cautious approach to patient selection and monitoring protocols.

The European Medicines Agency (EMA) has approved Leqembi, developed by Eisai and Biogen, for treating Alzheimer's disease in the EU. This decision comes after an initial rejection and is accompanied by recommendations for stringent patient screening and safety monitoring.
Leqembi is now indicated for use in patients with early-stage Alzheimer's disease. The EMA's approval stipulates that patients undergo initial genetic screening to identify potential risks. Furthermore, ongoing safety scans are mandated to monitor for any adverse effects during treatment.
The approval reflects a cautious approach to utilizing Leqembi, balancing the potential benefits against the need for careful patient selection and monitoring. The EMA's recommendations aim to optimize patient outcomes while minimizing potential risks associated with the drug.
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Reference News

[1]
Leqembi Secures EMA Thumbs Up For Narrower Indication
pink.pharmaintelligence.informa.com · Nov 14, 2024

After initial rejection, EMA approves Leqembi with recommendation for generic screening and ongoing safety scans.

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