From their meeting in November, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights.
They have recommended seven medicines for approval including three new medicines, two orphan medicines and two generics.
The Committee recommended granting a marketing authorisation for Isturisa (osilodrostat) for Cushing’s syndrome. A conditional marketing authorisation was also recommended for Polivy, a treatment for relapsed/refractory B-cell lymphoma. Mayzent for multiple sclerosis, Sunosi for sleep disturbance and Tavlesse for primary immune thrombocytopenia, also received positive opinions. The generic medicines, Clopidogrel/Acetylsalicylic acid Mylan and Deferasirox Accord were also recommended for marketing authorisations.
There were two recommendations for extensions of therapeutic indication, for Kadcyla and Revlimid. No negative opinions were recorded, however two applications for initial marketing authorisations were withdrawn for Linhaliq and Luxceptar. An application for the extended use of Opsumit to treat chronic thromboembolic pulmonary hypertension, was also withdrawn.
CHMP further re-iterated the recommendations by the Pharmacovigilance Risk Assessment Committee (PRACs), on the safety of Lemtrada and Xeljanz.
For the meeting summary, and the full list of approvals, opinions and withdrawals, please click here.