Green light for 10 new medicines in the EU

Ten new medicines have been recommended for approval by the European Medicines Agency (EMA), with another six products recommended for extension of their therapeutic indications.

This brings to 89 the number of new medicines given the green light in 2024. A total of 69 extensions of indication have also been issued between January and October 2024.

The newly-approved medicines include:

• Alhemo (concizumab), a medicine for routine prophylaxis of bleeding in patients with haemophilia A or B with inhibitors, two types of a rare inherited bleeding disorder.
• Fluad (surface antigen, inactivated, adjuvanted), intended for the prevention of flu in adults 50 years of age and older, and Flucelvax (surface antigen, inactivated, prepared in cell cultures), for flu prevention in adults and children from two years of age.
• Korjuny (catumaxomab) for the intraperitoneal treatment of malignant ascites, a build-up of fluid containing cancer cells in the abdomen of cancer patients.
• Siiltibcy (rdESAT-6 / rCFP-10) for the diagnosis of infection with Mycobacterium tuberculosis.
• Wainzua* (eplontersen) for the treatment of adults with hereditary transthyretin-mediated amyloidosis.
• Absimky (ustekinumab) and Imuldosa (ustekinumab), two biosimilar medicines intended for the treatment of paediatric plaque psoriasis, and adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease or ulcerative colitis.
• Buprenorphine Neuraxpharm (buprenorphine), a substitution treatment of opioid drug dependence.
• Eltrombopag Viatris (eltrombopag), a generic medicine for the treatment of children and adults with primary immune thrombocytopenia and thrombocytopenia associated with chronic hepatitis C.

Extensions of therapeutic indication were approved for Cerdelga (eliglustat), Hepcludex (bulevirtide), Kevzara (sarilumab), Kisqali (ribociclib), Tevimbra (tislelizumab) and Yselty (linzagolix choline).