EMA Recommends Five New Medicines for Approval
Three of the five are biosimilars, and seven additional medicines received recommendations for indication extensions.
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The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended five new medicines for approval, according to a summary of CHMP’s March 24–27, 2025 meeting (1). Another seven medicines were recommended for extensions of their therapeutic indications.
A recommendation for a marketing authorization was given to Xoanacyl (ferric citrate coordination complex) for the treatment of concomitant hyperphosphatemia and iron deficiency in adults with chronic kidney disease (1). CHMP also gave a positive opinion to Ryjunea (atropine), intended for slowing progression of myopia in children aged 3 to 14 years.
Three biosimilars also received positive opinions: Jubereq (denosumab), for prevention of skeletal-related events in adults with advanced malignancies involving bone and treatment of adults and skeletally mature adolescents with giant cell tumor of bone; Qoyvolma (ustekinumab), for treatment of plaque psoriasis in adults and children and psoriatic arthritis, Crohn’s disease, and ulcerative colitis in adults; and Osvyrti (denosumab), for treatment of osteoporosis in women who have been through menopause, men with prostate cancer who are at increased risk of fractures with bone loss linked to hormone ablation, and those whose bone loss is linked to long-term treatment with systemic glucocorticoids (1).
Recommended for extensions of indications were made for the following medicines already approved in the European Union: Bosulif (bosutinib), Calquence (acalabrutinib), Flucelvax (influenza vaccine—surface antigen, inactivated, prepared in cell cultures), Opdivo (nivolumab), Tevimbra (tislelizumab), Tremfya (guselkumab), and Xydalba (dalbavancin) (1).
Negative opinions were issued regarding two medicines. A recommendation was made not to grant a marketing authorization for Kisunla (donanemab), for the treatment of early Alzheimer’s disease, with CHMP saying that the benefits of the medicine were not enough to outweigh its risks of potentially fatal events due to amyloid-related imaging abnormalities (1). CHMP also recommended to refuse extending the marketing authorization for Pemazyre (pemigatinib), for treatment of myeloid/lymphoid neoplasms with fibroblast growth factor receptor 1 rearrangement.
For Opdivo, CHMP recommended a new pharmaceutical form as well as a new strength for subcutaneous administration (1).
“Preventing disease recurrence and improving long-term outcomes for patients with NSCLC [non-small cell lung cancer] earlier in the treatment journey is critical to addressing unmet needs and is one of our top priorities,” said Dana Walker, MD, vice-president, Opdivo global program lead, Bristol Myers Squibb, in a company press release (2). “With today's positive opinion from the CHMP, we are pleased that our second Opdivo -based regimen for certain patients with resectable NSCLC whose tumors have PD-L1 [programmed cell death ligand 1] expression ≥1%, is one step closer to being approved in the European Union.”
Applications for initial marketing authorizations for two medicines were withdrawn: Insulin Human Rechon (insulin human), for treatment of patients with diabetes who need insulin to control their blood glucose levels, and Cinainu (liquid ethanolic extract 30% [W/W] of Allium cepa fresh bulb and Citrus limon fresh fruit/dry aqueous extract of paullinia cupana seed/dry hydroethanolic extract of theobroma cacao seed), an herbal medicine for treatment of moderate-to-severe alopecia areata (1). Also, an application to extend the use of Amyvid (florbetapir [18F]) in adults, to monitor their response to treatments reducing beta amyloid plaques, was withdrawn.
CHMP said it finalized a review of Orexigen Therapeutics Ireland’s Mysimba (naltrexone/bupropion), used for weight management in adults with obesity or who are overweight, because of concerns about potential long-term cardiovascular risk, but concluded that more information must be provided from an ongoing study on the medicine’s cardiovascular effects in patients treated for more than one year (1).
References
1. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 24–27 March 2025. Press Release. March 28, 2025.
2. Bristol Myers Squibb. Bristol Myers Squibb Receives Positive CHMP Opinion for Perioperative Regimen of Neoadjuvant Opdivo (nivolumab) and Chemotherapy Followed by Surgery and Adjuvant Opdivo for Resectable Non-Small Cell Lung Cancer in Patients with Tumor Cell PD-L1 Expression ≥1%. Press Release. March 28, 2025.
