From their meeting in February, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. During the meeting the CHMP announced the recommendations of eight medicines for approval, including two orphan medicines. For three out of the eight new medicines, the CHMP recommended a conditional marketing authorisation.
A conditional marketing authorisation was granted for Ondexxya (andexanet alfa), which is to be used as an antidote for adult patients who take the anticoagulant medicines apixaban or rivaroxaban, when reversal of the mechanism of action of the medicine is required due to life-threatening or uncontrolled bleeding.
Waylivra (volanesorsen), which was designated as an orphan medicine during its development, was also granted a conditional marketing authorisation. Waylivra is the first medicine for the treatment of familial chylomicronaemia syndrome; a rare genetic disease which stops the body from breaking down fats.
The CHMP recommended extensions of therapeutic indication for Dupixent, Lynparza, Riarify, Trydonis and Viread. The initial marketing authorisation application for Epjevy (pacritinib citrate) was withdrawn.
For the meeting summary, and a full list of approvals, opinions and withdrawals, please click here.