CHMP recommends Artesunate Amivas for the initial treatment of severe malaria – Amivas
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Artesunate Amivas, intended for initial treatment of severe malaria in adults and children.
The applicant for this medicinal product is Amivas Ireland Ltd. Artesunate Amivas will be available as 110 mg powder and solvent for solution for injection. The active substance of Artesunate Amivas is artesunate, an antiprotozoal (ATC code: P01BE03) which is expected to generate an unstable organic free radical followed by alkylation. The free radical binds to malarial proteins, triggering the destruction of parasite membranes.
The main benefit of Artesunate Amivas is improved in-hospital survival for patients suffering severe malaria. The most common side effects consist of delayed post-treatment red blood cell lysis (breakdown), anaemia, and reduced reticulocyte count.