EMA CHMP recommends seven medicines for approval in November 2026
- Positive opinions covered three new medicines, two insulin aspart biosimilars and two generic or hybrid medicines.
- The CHMP recommended extending the indications of 11 authorised medicines, including Gazyvaro for systemic lupus erythematosus.
- A 100 mg dapivirine vaginal ring was recommended for use outside the EU, allowing replacement every three months.
- The committee confirmed refusals for KemSu and Meplyffa and recorded withdrawals of applications for Amlypave and Qezzaqar.
New medicine recommendations
The CHMP recommended marketing authorisations for seven medicines: Aumseqa (aumolertinib) for non-small cell lung cancer, Baxfendy (baxdrostat) for insufficiently controlled hypertension and Zybrivo (sintilimab) for non-squamous non-small cell lung cancer in adults. It also issued positive opinions for the insulin aspart biosimilars Garzulys and Donrafylix, and generic medicines Fondaparinux sodium Evumed and Ruxolitinib Krka.
Indication extensions and dapivirine ring
The committee recommended extensions for 11 medicines, including Gazyvaro for adults with active systemic lupus erythematosus and Isturisa for Cushing’s syndrome in patients aged six years and older. The other medicines are Bexsero, Cosentyx, Dovato, Enflonsia, Steglatro, Sunlenca, Talzenna, Tivicay and Welireg.
For use outside the EU, the CHMP recommended a 100 mg dapivirine vaginal ring to reduce the risk of HIV-1 infection. The new strength can be replaced every three months instead of monthly.
Re-examinations and withdrawals
The committee confirmed its recommendation to refuse marketing authorisations for KemSu, for acute pain in children and adolescents, and Meplyffa, for Niemann-Pick disease type C. Applications for Amlypave, for kappa light chain amyloidosis, and Qezzaqar, for two types of soft tissue sarcoma, were withdrawn.
Safety communication
A direct healthcare professional communication on Mounjaro (tirzepatide) advises women using oral contraceptives to add a barrier method for four weeks after starting treatment and after each dose increase, or to switch to a non-oral contraceptive method. The communication notes limited information on tirzepatide’s effect on oral contraceptives.
Source: EMA