EU gives green light for 14 new medicines

The European Medicines Agency (EMA) has approved fourteen new medicines at a summer meeting, with a further eleven products recommended for extension of therapeutic indications. The Agency’s human medicines committee (CHMP) has now authorised seventy-one medicines in 2024.

Newly-approved products:

• Anzupgo (delgocitinib), a medicine intended for the treatment of moderate to severe chronic hand eczema in adults for whom topical corticosteroids are inadequate or inappropriate.
• Iqirvo (elafibranor), for the treatment of primary biliary cholangitis, a chronic and progressive autoimmune disease that can cause liver damage.
• Kayfanda (odevixibat), for the treatment of cholestatic pruritus in patients with Alagille syndrome, a rare, life-threatening genetic disorder with a wide variety of clinical manifestations affecting the liver, heart, skeleton, eyes, skin, central nervous system, kidneys, and facial features.
• Loqtorzi (toripalimab), for the treatment of nasopharyngeal carcinoma and oesophageal squamous cell carcinoma.
• Vevizye (ciclosporin), for the treatment of adult patients with moderate to severe dry eye disease which has not improved despite treatment with tear substitutes.
• Vyloy (zolbetuximab), to treat gastric or gastro-oesophageal junction adenocarcinoma, a cancer of the stomach.
• Yuvanci (macitentan / tadalafil), for the treatment of pulmonary arterial hypertension, a chronic and progressive disease of the small pulmonary arteries that is characterised by vascular proliferation and remodelling.

The Committee adopted positive opinions for six biosimilar medicines:

• Eksunbi (ustekinumab) and Fymskina (ustekinumab), for the treatment of plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease.
• Ituxredi (rituximab), for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis and pemphigus vulgaris.
• Otulfi (ustekinumab), for the treatment of plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis and Crohn’s disease.
• Ranibizumab Midas (ranibizumab), for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion and visual impairment due to choroidal neovascularisation.
• Tuznue (trastuzumab), for the treatment of breast and gastric cancer.

Marketing authorisation was also approved for Axitinib Accord (axitinib), a generic medicine for the treatment of adult patients with advanced renal cell carcinoma.

Extensions of indication were recommended for eleven products that are already available in the EU for the treatment of other conditions: Arexvy, Braftovi, Edurant, Keytruda, Mektovi, Opsumit, Padcev, Rybrevant, Slenyto, Spevigo and Tecentriq.

In addition, the CHMP finalised its assessment of an application to extend the use of the weight loss medicine Wegovy (semaglutide) to include prevention of major cardiovascular problems in adults with established cardiovascular disease and a body mass index (BMI) of at least 27 kg/m2.

The CHMP considered that this use is already covered by the approved indication for weight management and therefore did not agree to add a separate indication for the prevention of cardiovascular disease. Instead, it recommended to include additional information from a study in the product information.