Green light for 16 new medicines in the EU

April was a bumper month for drug approvals in Europe, with sixteen new products recommended by the European Medicines Agency’s (EMA) key committee on human medicines.

This almost doubles the number of drugs approved in 2025, bringing the annual total to 33. A further ten products had their therapeutic indications extended.

The newly-approved products were:

• Alyftrek (deutivacaftor / tezacaftor / vanzacaftor), a medicine intended for the treatment of cystic fibrosis in people aged six years and older who have at least one non class I mutation in the cystic fibrosis transmembrane conductance regulator gene.
• Attrogy (diflunisal) for the treatment of hereditary transthyretin-mediated amyloidosis, a disease in which abnormal proteins called amyloids build up in tissues around the body including around the nerves.
• Duvyzat (givinostat), conditionally approved as a treatment for Duchenne muscular dystrophy (DMD) in patients from the age of six who can walk.
• Sephience (sepiapterin) for the treatment of hyperphenylalaninaemia in adults and children with phenylketonuria.
• Tepezza (teprotumumab) for the treatment of adults with moderate to severe Thyroid Eye Disease (TED), also known as Graves’ Eye Disease, a rare autoimmune disease that triggers inflammation of muscles, fat, and other tissues around and behind the eyes.
• Ziihera (zanidatamab), for the treatment of adults with unresectable locally advanced or metastatic HER2-positive biliary tract cancer.
• Oczyesa (octreotide) for the treatment of adults with acromegaly, a disease that leads to excessive growth, particularly of bones in the hands, feet and face caused by too much growth hormone.

The committee adopted positive opinions for nine biosimilar medicines:

• Dazublys (trastuzumab) for the treatment of metastatic and early breast cancer.
• Denbrayce (denosumab), Enwylma (denosumab), Vevzuo (denosumab) and Yaxwer (denosumab), for the prevention of skeletal related events in adults with advanced malignancies, treatment of adults and skeletally mature adolescents with giant cell tumour of bone.
• Denosumab BBL (denosumab), Izamby (denosumab), Junod (denosumab) and Zadenvi (denosumab), for the treatment of osteoporosis and bone loss.