From their meeting in December, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights.
December’s meeting saw fifteen medicines recommended for approval including five new medicines, three orphan medicines, two biosimilars and five generic/hybrids.
A marketing authorisation was recommended, via the EMA’s accelerated access programme, for Enhertu (trastuzumab deruxtecan) for the treatment of metastatic HER2-positive breast cancer. A marketing authorisation was also recommended under exceptional circumstances for Kumoxiti (moxetumomab pasudotox) for relapsed or refractory hairy cell leukaemia. Retsevmo (selpercatinib) for various RET-fusion cancers and Sibnayal (potassium citrate/potassium hydrogen carbonate) for distal renal tubular acidosis were also recommended for conditional marketing authorisations.
The committee adopted positive opinions for Heplisav B (hepatitis B surface antigen) for active immunisation against hep B virus infection, Rukobia (fostemsavir) for multidrug resistant HIV-1 infection, Inrebic (fedratinib) for primary myelofibrosis and and Tukysa (tucatinib) for HER2-positive metastatic breast cancer.
The CHMP recommended granting marketing authorisations for the biosimilar medicines Kixelle (insulin aspart) to treat diabetes mellitus, and Yuflyma (adalimumab) for various autoimmune disorders.
Four generic medicines including Lenalidomide Krka, Lenalidomide Krka d.d., Lanalidomide Krka d.d. Novo mesto and Sunitinib Accord were recommended for marketing authorisations. The hybrid medicine Ogluo (glucagon) for severe hypoglycaemia was also recommended for a marketing authorisation.
Additionally, there were nine recommendations for extensions of therapeutic indications including Bavencio, Doptelet, Iscover, Keytruda, Nplate, Nordimet, Plavix, Rinvoq and Spravato.
The CHMP also adopted a restriction of indication for Veklury (remdesivir). A change to the product information to provide clearer instructions in which COVID-19 patients it should be used was recommended.
The application for an initial marketing authorisation for Artobend (autologous human chondrocytes in vitro expanded) to treat cartilage defects in the knee, was withdrawn.
A detailed report of the meeting outcomes can be found here.