From their meeting in February, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights.
At this meeting there were five recommendations for approvals of medicines, including two orphan medicines. A marketing authorisation for Amglidia (glibenclamide) was granted for the treatment of neonatal diabetes mellitus in newborns, infants and children. Neonatal diabetes is a very rare disease and thus Amglidia was granted an orphan designation.
Two informed consent applications were granted a positive opinion from the CHMP for the maintenance treatment of adult patients with moderate to severe chronic obstructive pulmonary disease. An informed consent application “makes use of data from the dossier of a previously authorised medicine, with the marketing authorisation holder of that medicine giving consent for the use of their data in the application.”
The CHMP adopted negative opinions on two medicines, and stated six recommendations on extensions of therapeutic indication.
For the meeting summary, and a full list of approvals, opinions and withdrawals, please click here.