From their meeting in May, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights.
At this meeting there were nine recommendations for approvals of medicines, including two orphan medicines. The CHMP recommended granting a marketing authorisation for Aimovig (erenumab), the first human monoclonal antibody therapy for prevention of migraine. Myalepta (metreleptin) received a positive opinion for the treatment of leptin deficiency, and was designated as an orphan medicine. Four biosimilar medicines also received a positive opinion from the Committee.
The CHMP adopted a negative opinion, thus refusing a marketing authorisation, for Exondys (eteplirsen). Exondys was expected to be used to treat Duchenne muscular dystrophy. There were also three recommendations on extension of therapeutic indication. The application for an initial marketing authorisation for Restaysis (ciclosporin) was withdrawn. This medicine was intended to be used for the treatment of moderate dry eye disease.
For the meeting summary, and a full list of approvals, opinions and withdrawals, please click here.