From their meeting in January, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights.
January’s meeting saw thirteen medicines recommended for approval including seven new medicines, three orphan medicines, two biosimilars and one generic/hybrid.
Marketing authorisations were recommended for Byfavo (remimazolam) used in procedural sedation and for Vazkepa (icosapent ethyl) to reduce the likelihood of cardiovascular events in patients at high cardiovascular risk. Conditional marketing authorisations were also recommended for Nexpovio (Selinexor) used to treat relapsed and refractory multiple myeloma and Pemazyre (pemigatinib) for the second-line treatment of advanced or metastatic cholangiocarcinoma (bile duct cancer) characterised by fusion or rearrangements of fibroblast growth factor receptor 2.
The committee adopted positive opinions on Seffalair Spiromax (salmeterol/fluticasone) and BroPair Spiromax (salmeterol/fluticasone) for the treatment of asthma in adults and adolescents aged 12 years and older, Kesimpta for the treatment of adult patients with active relapsing forms of multiple sclerosis, Ontozry (cenobamate) for the treatment of adults with epilepsy whose disease is not adequately controlled despite a history of treatment with at least two anti-epileptic medicinal products, and Sogroya (somapacitan) for the treatment of growth hormone deficiency in adults. A further conditional marketing authorisation was recommended for COVID-19 Vaccine AstraZeneca (COVID-19 Vaccine (ChAdOx1-S [recombinant])) to prevent COVID-19 in people from 18 years of age.
Additionally, a positive opinion was adopted by the committee for the biosimilar medicines Alymsys (bevacizumab) and Oyavas (bevacizumab) to treat carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.
The generic medicine Thiotepa Riemser (thiotepa) for use as a conditioning treatment before haematopoietic progenitor cell transplantation also received a positive opinion.
There were three recommendations for extensions of therapeutic indications including Keytruda, Sirturo and Vaxchora. The committee also recommended the addition of a new strength (150mg), new pharmaceutical form (solution for injection) and new route of administration (subcutaneous use) for Tysabri, a multiple sclerosis medicine already authorised for intravenous use.
The applications for initial marketing authorisations for Dexamethasone Taw (dexamethasone phosphate) to treat several inflammatory and other conditions, and Tecentriq (atezolizumab) to treat advanced or metastatic urothelial cancer in combination with platinum-based therapy in patients who had not been treated before, were withdrawn.
A detailed report of the meeting outcomes can be found here.