March 2024 EMA/CHMP new medicines recommendations for approval

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended six novel medicines for approval at its March 2024 meeting. Confirmations from the European Commission are normally announced within two or three months.

The CHMP recommended granting a marketing authorization for Denmark-based Novo Nordisk’s (NOV: N) Awiqli (insulin icodec) for the treatment of diabetes mellitus in adults. The positive CHMP opinion is based on results from the ONWARDS Phase IIIa clinical trial program. Once-weekly basal insulin icodec achieved superior blood sugar reduction (measured by a change in HbA1c) and superior Time in Range (time spent within recommended blood sugar range), compared with daily basal insulin in people with type 2 diabetes. In people with type 2 diabetes who have not previously been treated with insulin.

The CHMP recommended granting a marketing authorization for Dutch drugmaker Norgine’s Agilus (dantrolene sodium, hemiheptahydrate), indicated in adults and children of all ages iqlithe skeletal muscles of the body are over-stimulated and are unable to relax.