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Sixteen medicines have been recommended for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) at its July 2018 meeting.
Among the drugs recommended for approval were tezacaftor/ivacaftor (Symkevi; Vertex Pharmaceuticals [Europe]), an orphan drug for the treatment of cystic fibrosis, and eravacycline (Xerava; Tetraphase Pharmaceuticals), a new antibacterial medicine for the treatment of complicated intra-abdominal infections in adults.
The CHMP also recommended melatonin (Slenyto; RAD Neurim Pharmaceuticals) for the treatment of insomnia in children and adolescents with autism spectrum disorder and tildrakizumab (Ilumetric; Almirall) for the treatment of moderate to severe plaque psoriasis.
Four cancer medicines were recommended for approval, including durvalumab (Imfinzi; AstraZeneca) for the treatment of non-small cell lung cancer and abemaciclib (Verzenios; Eli Lilly) for the treatment of locally advanced or metastatic breast cancer.
Three generic medicines were recommended by the CHMP for a marketing authorisation, including lenalidomide (Lenalidomide Accord; Accord Healthcare) for the treatment of multiple myeloma.
At the meeting, the CHMP confirmed its decision to refuse a marketing authorisation for betrixaban (Dexxience; Portola Pharmaceuticals) for the prevention of venous thromboembolism, on the grounds that the main study did not “satisfactorily show” the drug’s effectiveness in preventing blood clots in patients admitted to hospital.
It also confirmed it was not approving abaloparatide (Eladynos; Radius International) for the treatment of osteoporosis because it decided the main study did not show that the drug was effective at preventing non-vertebral fractures in women who have been through the menopause.
Recommendations for the extension of therapeutic indications was given for 12 medicines, including two additional indications for pembrolizumab (Keytruda; Merck Sharp & Dohme) – for first-line treatment of metastatic non-squamous non-small–cell lung carcinoma, and as a monotherapy for the treatment of recurrent or metastatic head and neck squamous cell carcinoma, both in specific instances.
The agenda and minutes for the CHMP’s meetings are available to view on the EMA website.
