EMA’s human medicines committee (CHMP) recommended five medicines for approval at its March 2025 meeting.
The committee recommended granting a marketing authorisation for Xoanacyl (ferric citrate coordination complex), 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 Ryjunea (atropine sulfate), 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-authorised reference product and in part on new data.
The CHMP adopted positive opinions for three biosimilar medicines:
The committee recommended not granting a marketing authorisation for Kisunla (donanemab), a medicine intended for the treatment of early Alzheimer’s disease. The committee considered that the benefits of this medicine were not large enough to outweigh the risk of potentially fatal events due to amyloid-related imaging abnormalities (ARIA), involving swelling and potential bleedings in the brain.
For more information on this negative opinion, see the question-and-answer document in the grid below.
The committee recommended extensions of indication for seven medicines that are already authorised in the European Union (EU): Bosulif, Calquence, Flucelvax, Opdivo, Tevimbra, Tremfya and Xydalba.
For Opdivo, the committee also recommended a new pharmaceutical form and a new strength for subcutaneous administration.
The CHMP recommended to refuse extending the marketing authorisation for Pemazyre* (pemigatinib) for the treatment of myeloid/lymphoid neoplasms with fibroblast growth factor receptor 1 (FGFR1) rearrangement (changes in the FGFR1 gene that produce an abnormal form of a protein called FGFR1). Myeloid/lymphoid neoplasms are very rare cancers that affect the bone marrow and the white blood cells.
For more information on this negative opinion, see the question-and-answer document in the grid below.
Applications for initial marketing authorisation for two medicines were withdrawn:
The application to extend the use of Amyvid (florbetapir (18F)) in adults to monitor their response to treatments that reduce beta amyloid plaques was withdrawn.
Question-and-answer documents on the withdrawals of these medicines are available in the grid below.
The committee finalised its review of Mysimba (naltrexone / bupropion), a medicine used for weight management in adults with obesity or overweight. The review was prompted by concerns about a potential long-term cardiovascular risk (affecting the heart and blood circulation) with the medicine. The CHMP concluded that the benefits of Mysimba continue to outweigh its risks. However, the company must provide more information from an ongoing study on the medicine’s cardiovascular effects in patients treated for more than one year. New measures are also being implemented to minimise potential cardiovascular risks with long-term use.
For more information on this recommendation see the public health communication in the grid below.
The agenda of the March 2025 CHMP meeting is published on EMA's website. Minutes of the meeting will be published in the coming weeks.
Key figures from the March 2025 CHMP meeting are represented in the graphic below.
*This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity.
Ferric citrate coordination complex
Averoa
Treatment of concomitant elevated serum phosphorous and iron deficiency in adult patients with chronic kidney disease (CKD).
denosumab
Accord Healthcare S.L.U.
Prevention of skeletal related events in adults with advanced malignancies involving bone.
ustekinumab
Celltrion Healthcare Hungary Kft.
Treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.
denosumab
Accord Healthcare S.L.U.
Treatment of osteoporosis and bone loss.
atropine sulfate
Santen Oy
Treatment of progression of myopia in children aged 3 to 18 years.
bosutinib
Pfizer Europe Ma EEIG
acalabrutinib
AstraZeneca AB
influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Seqirus Netherlands B.V.
nivolumab
Bristol-Myers Squibb Pharma EEIG
tislelizumab
BeiGene Ireland Ltd
guselkumab
Janssen-Cilag International N.V.
dalbavancin
AbbVie Deutschland GmbH & Co. KG
donanemab
Eli Lilly Nederland B.V.
To slow disease progression in adult patients with Alzheimer’s disease (AD).
pemigatinib
Incyte Biosciences Distribution B.V.
naltrexone / bupropion
Orexigen Therapeutics Ireland Limited
insulin human
Rechon Life Science AB
liquid ethanolic extract of Allium cepa (onion) fresh bulb and Citrus limon (lemon) fresh fruit / dry aqueous extract of Paullinia cupana (guarana) seed / dry hydroethanolic extract of Theobroma cacao (cocoa) seed
Legacy Healthcare (France) S.A.S.
florbetapir (18F)
Eli Lilly Nederland B.V.