EMA approves eight new medicines

The EU drug watchdog, the European Medicines Agency (EMA), has given the green light for eight new medicines at its May meeting. This brings to 36 the number of new medicines granted marketing authorisation in the EU this year. The newly approved products include:

• Jascayd (nerandomilast) for the treatment of idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF), two serious lung diseases that involve progressive and irreversible scarring (fibrosis) of the lung tissue.
• Vijoice (alpelisib) for the treatment of patients with severe PIK3CA-related overgrowth spectrum (PROS) disorders.
• Boey (trenibotulinumtoxinE) for the temporary improvement in the appearance of moderate to severe lines between the eyebrows when these have an important psychological impact in adults.
• Etcamah (camizestrant) for the treatment of adults with locally advanced or metastatic breast cancer with a specific mutation in the ESR1 gene.
• Ablymico (liraglutide), indicated for weight management.
• Liraglutide STADA (liraglutide) for the treatment of insufficiently controlled type 2 diabetes as an adjunct to diet and exercise.
• Colchicine AGEPHA Pharma (colchicine) for the secondary prevention of atherothrombotic events in adults with coronary disease who have been stable for at least six months.
• Vislyfa (ranibizumab) for the treatment of neovascular age-related macular degeneration, visual impairment and other retinopathies.

The committee recommended extensions of indication for 13 medicines that are already authorised in the European Union (EU): Braftovi, Enhertu, Erbitux, Fasenra, Hetronifly, Iclusig, Keytruda, Maviret, Padcev, Palynziq, Sogroya, Tepkinly and Trodelvy.