Five new medicines backed for approval by EMA's CHMP at Feb meeting
Following its monthly meeting in February, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five medicines for approval, including two orphan medicines.
The recommendations will be reviewed for final decisions by the European Commission, which normally come through within two or three months.
The CHMP recommended granting a marketing authorisation for Amglidia (glibenclamide), from French company AMMTeK, for the treatment of neonatal diabetes mellitus in newborns, infants and children. Because neonatal diabetes is a very rare disease, Amglidia was granted an orphan designation.
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