From their meeting in April, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights.
April’s meeting saw eight medicines recommended for approval including two new medicines, two orphan medicines, one biosimilar and three generic/hybrid medicines.
The Committee recommended granting a marketing authorisation for Enerzair breezhaler (indacaterol, glycopyrronium, mometasone furoate), a triple combination therapy for asthma, which included an optional smart electronic sensor which collects data on patient use. Zimbus Breezhaler, which contains the same active ingredients, also received a positive opinion for the same indication.
Two orphan medicines were also recommended for approval. Daurismo (glasdegib) for acute myeloid leukaemia, and Reblozyl (luspatercept) for transfusion-dependent anaemia associated with myelodysplastic syndromes or beta-thalassaemia.
CHMP recommended a marketing authorisation for the hybrid medicine Cabazitaxel Accord (cabazitaxel) for hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. Paliperidone Janssen-Cilag International (paliperidone) received a positive opinion via an informed consent application. The generic medicine Fingolimod Accord (fingolimod) received positive opinion for the treatment of relapsing-remitting multiple sclerosis with high disease activity.The biosimilar medicine Insulin aspart Sanofi also received a positive opinion for diabetes mellitus.
Furthermore, there were nine recommendations for extensions of therapeutic indications, including Braftovi, Cablivi, Carmustine Obvius, Ecalta, Harvoni, Kalydeco, Sovaldi, Taltz and Ultomiris.
CHMP recommended the suspension of all rantidine medicines in the EU as the outcome of a review. Low levels of nitrosamine impurities have consistently been found in these products. Outcomes of reviews on fluorouracil medicines and Picato were also reported.
A detailed report of the meeting outcomes can be found here.