Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2024

14 new medicines recommended for approval; another seven medicines are recommended for extension of their therapeutic indications

EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its May 2024 meeting.

The CHMP recommended granting a marketing authorisation under exceptional circumstances for Adzynma* (rADAMTS13) an enzyme replacement therapy indicated for the treatment of children and adult patients with congenital thrombotic thrombocytopenic purpura, a rare, life-threatening blood disorder characterised by blood clotting in small blood vessels throughout the body that can result in organ damage and premature death.

Akantior* (polyhexanide) received a positive opinion for the treatment of acanthamoeba keratitis, a severe, progressive and sight threatening corneal infection characterised by intense pain and photophobia. Acanthamoeba keratitis is a rare disease primarily affecting contact lens wearers…