bullish
CHMP Meeting Update: 4 New Medicines Recommended For Approval, Reinstates Previous Leqembi Decision
355 Views03 Mar 2025 00:30
SUMMARY
- EMA’s human medicines committee (CHMP) recommended three new medicines for approval and adopted positive opinion for one generic medicine at its February 2025 meeting.
- The committee recommended extending the therapeutic indications of 16 existing medicines, including two cystic fibrosis medicines, KAFTRIO and KALYDECO and oncology drugs CALQUENCE, DARZALEX, ENHERTU, and RINVOQ .
- The CHMP concluded that its opinion recommending a marketing authorization for Eisai's Alzheimer’s disease drug Leqembi does not need to be updated.
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Tina Banerjee
Global Healthcare Analyst
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