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), 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:
* **Jubereq** (denosumab), for the prevention of skeletal-related events in adults with advanced malignancies involving bone and the treatment of adults and skeletally mature adolescents with giant cell tumour of bone.
* **Qoyvolma** (ustekinumab), for the treatment of plaque psoriasis in adults and children; and treatment of psoriatic arthritis, Crohn’s disease and ulcerative colitis in adults.
* **Osvyrti** (denosumab), for the treatment of osteoporosis in women who have been through menopause, in men with prostate cancer who are at increased risk of fractures and whose bone loss is linked to hormone ablation, and people whose bone loss is linked to long-term treatment with systemic glucocorticoids.
### Negative opinion for one medicine
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.
### Recommendations on extensions of therapeutic indication for seven medicines
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.
### Negative opinion for one extension of indication
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.
### Withdrawal of applications
Applications for initial marketing authorisation for two medicines were withdrawn:
* **Insulin Human Rechon** (insulin human), intended for the treatment of patients with diabetes who need insulin to control their blood glucose (sugar) level;
* **Cinainu** (rilonacept), developed as a herbal medicine for the treatment of moderate-to-severe alopecia areata, a disease causing hair loss of the scalp or other parts of the body.
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.
### Conclusion of referral
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.
### Agenda and minutes
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.
### CHMP statistics
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.
