From their meeting in January, The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights.
They have recommended FIFTEEN medicines for approval including seven new medicines, two orphan medicines, one biosimilar, four generic and two hybrid medicines.
The Committee has recommended granting a marketing authorisation for Givlaari (givosiran), which is the first treatment for the life-threatening condition acute hepatic porphyria, in those aged 12 years and older. This medicine went through accelerated assessment, via the EMA’s PRIME scheme, due to its potential for treating an unmet medical need.
Marketing authorisations are also recommended for Vaxchora as a cholera vaccine, Nilemdo and Nustendi for the treatment of primary hypercholesterolaemia and mixed dyslipidaemia. Other new medicines, including Rybelsus (semaglutide) and Liumjev (insulin lispro) for diabetes, Nubeqa (darolutamide) for prostate cancer, and Staquis (crisaborole) for atopic dermatitis, have all received positive opinions.
The generic medicines Azacitidine betapharm, Azacitidine Mylan, Arsenic trioxide Mylan and Cinacalcet Accordpharma are also recommended for marketing authorisations. The hybrid medicines budesonide/formoterol Teva Pharma B.V. for asthma and chronic obstructive pulmonary disease (COPD), and Trepulmix for chronic thromboembolic pulmonary hypertension have also received recommendations for marketing authorisations.
The biosimilar medicine Ruxience (rituximab) has received a positive opinion for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and Pemphigus vulgaris.
Additionally, there are six recommendations for extensions of therapeutic indication. However, the application to extend the use of Keytruda for the treatment of oesophageal cancer has been withdrawn.
A detailed report of the outcomes of the meeting can be found here.