Nine new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its May 2022 meeting.
A recommendation for marketing authorisation was adopted for Cevenfacta (eptacog beta (activated)) for the treatment of bleeding episodes in patients with congenital haemophilia.
The CHMP gave a positive opinion under exceptional circumstances for a new gene therapy, Upstaza* (eladocagene exuparvovec). It is the first medicine intended to treat adult and paediatric patients with aromatic L‑amino acid decarboxylase (AADC) deficiency, an ultra-rare genetic disorder affecting the nervous system. See more information in the news announcement in the grid below…