March 2025 EMA/CHMP meeting new drug opinions
The European Medicines Agency’s (EMA’) human medicines committee (CHMP) has recommended two new medicines and three biosimilars for approval at its March 2025 meeting.
The committee recommended granting a marketing authorization for Xoanacyl (ferric citrate coordination complex), from Averoa,indicated for the treatment of concomitant hyperphosphataemia (high blood levels of phosphate) and iron deficiency in adults with chronic kidney disease, a condition in which the kidneys are damaged and cannot filter the blood as well as they should.
The CHMP adopted a positive opinion for Japanese drugmaker Santen’s (TYO: 4536) Ryjunea (atropine), intended for slowing the progression of myopia (short-sightedness) in children aged 3 to 14 years. This medicine was submitted in a hybrid application, which relies in part on the results of pre-clinical tests and clinical trials of an already-authorized reference product and in part on new data.
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