CHMP meeting highlights – February 2025

Four medicines were recommended for approval at the EMA’s human medicines committee (CHMP)’s February 2025 meeting.

A marketing authorisation for Deqsiga (human normal immunoglobulin) was granted as a replacement therapy for primary or secondary immunodeficiencies and immunomodulation in individuals with certain autoimmune conditions.

The group recommended authorisation of two medicines for oncology indications. For the first medicine, Lynozyfic (linvoseltamab) received a conditional authorisation recommendation for relapsed and refractory multiple myeloma.

Secondly, Trabectedin Accord (trabectedin) received a positive opinion for advanced soft tissue sarcoma and relapsed platinum-sensitive ovarian cancer.

A positive opinion was granted for Vyjuvek (beremagene geperpavec) to treat wounds resulting from the genetic skin disorder dystrophic epidermolysis bullosa. The US Food and Drug Administration (FDA) granted approval of the gene therapy in May 2023.

CHMP’s indication extension recommendations

The committee recommended extending indications for several medicines, including two medicines for rare diseases.

CHMP recommended Kaftrio (ivacaftor/tezacaftor/elexacaftor) and Kalydeco (ivacaftor) for combination use in cystic fibrosis patients two years old and over with at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Fabhalta (iptacopan) received a positive opinion for an indication extension to treat adults with the ultra-rare kidney disease complement 3 glomerulopathy.

Following its approval by the FDA in 2023, the CHMP has recommended extending the existing indication of the chikungunya vaccine Ixchiq (chikungunya vaccine (live)), to individuals from 12 years old.

Furthermore, the committee recommended extending indications of 12 medicines: Abrysvo, Calquence, Columvi, Darzalex, Enhertu, Imfinzi, Jaypirca, Prevymi, Rinvoq, Stelara, Supemtek Tetra and Tremfya.

Re-examinations of marketing authorisation recommendations

Following re-examination of its initial positive opinion, the CHMP confirmed its decision to extend the indication for Keytruda (pembrolizumab) as a medicine for unresectable non-epithelioid malignant pleural mesothelioma.

After its re-examination, the CHMP has refused recommendation of Kizfizo (temozolomide) to treat the rare cancer neuroblastoma.

Application withdrawals

Applications for initial marketing authorisations for two medicines were withdrawn, CHMP confirmed:

• Pelgraz Paediatric (pegfilgrastim) to treat neutropenia and prevent febrile neutropenia in children with cancer
• Rilonacept FGK Representative Service GmbH (rilonacept) intended as a treatment for individuals from 12 years old with recurring idiopathic pericarditis.

The committee also withdrew the application for an indication extension of Dupixent to treat moderate-to-severe chronic spontaneous urticaria in individuals aged 12 years old and older.