EMA recommends five new medicines for approval in the EU

The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has issued a positive opinion for five new medications, which are pending final authorization from the European Commission. This was announced by the regulator.

Among them is Redemplo – a therapy for adults with familial chylomicronemia syndrome, a rare genetic disorder associated with dangerously high triglyceride levels and a risk of pancreatitis. The medicine is administered via subcutaneous injection once every three months and aims to reduce fat deposits and complications in patients.

A positive assessment was also received by Cenrifki for the treatment of non-relapsing secondary progressive multiple sclerosis, as well as the gene therapy Itvisma, intended for patients with spinal muscular atrophy.

The list also includes the biosimilar medicine Rexatilux, used for various eye diseases leading to visual impairment.

Approval is also recommended for the generic medication Palbociclib Viatris for the treatment of breast cancer.

With these five new recommendations, the total number of medications receiving a positive opinion from the EMA since the beginning of 2026 reaches 28. The decision of the European Commission will finalise their marketing authorisation within EU countries.