From their meeting in September, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. During the meeting Harald Enzmann was elected as their new chair, for a three-year mandate starting on 21st September.
At this meeting there were thirteen recommendations for approvals of medicines, including three orphan medicines. The Committee recommended granting a marketing authorisation for the gene therapy Luxturna (voretigene neparvovec), for the treatment of adults and children with inherited retinal dystrophy caused by RPE65 gene mutations. A marketing authorisation was also recommended for a new antibiotic, Vabomere (meropenem trihydrate/vaborbactam), for the treatment of various severe infections in adults.
Re-examination of the Committee’s negative opinion for the medicine Exondys (eteplirsen) adopted at the May 2018 meeting, confirmed its previous recommendation to refuse the granting of a marketing authorisation for this medicine. At the meeting there were seven recommendations on extensions of therapeutic indication.
Applications for initial marketing authorisations for Entolimod TMC (entolimod) and Treprostinil SciPharm Sàrl (treprostinil) have been withdrawn. Treprostinil SciPharm Sàrl was intended to be used to treat chronic thromboembolic pulmonary hypertension.
For the meeting summary, and a full list of approvals, opinions and withdrawals, please click here.