EMA/CHMP May 2024 new medicines recommendations

31 May 2024

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended eight novel drugs for approval at its May 2024 meeting.

The CHMP recommended granting a marketing authorization under exceptional circumstances for Japanese pharma major Takeda’s (TYO: 450) 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), from SIFA SpA, received a positive opinion for the treatment of acanthamoeba keratitis, a severe, progressive and sight threatening corneal infection characterized by intense pain and photophobia. Acanthamoeba keratitis is a rare disease primarily affecting contact lens wearers.

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