Posted by Michael Wonder on 24 Feb 2018
Highlights from February 2018 CHMP meeting
23 February 2018 - Five medicines recommended for approval, including two orphans.
The EMA's CHMP recommended five medicines for approval, including two orphan medicines1, at its February 2018 meeting.
The CHMP recommended granting a marketing authorisation for Amglidia (glibenclamide), 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.
The cancer medicine Mylotarg (gemtuzumab ozogamicin) received a positive opinion for the treatment of acute myeloid leukaemia in patients aged 15 years and above, giving young patients a new treatment option. Mylotarg has an orphan designation.
The Committee recommended granting a marketing authorisation for Alpivab (peramivir), for the treatment of uncomplicated influenza.
