EMA adopted a positive opinion for the marketing authorization of arsenic trioxide medac for the treatment of acute promyelocytic leukaemia (blood cancer). The drug will be available as a 1 mg/mL concentrate for solution for infusion. The active substance is arsenic trioxide, an antineoplastic agent. Its mechanism of action is not completely understood, but it causes fragmentation, damage or degradation of DNA and the fusion protein pro-myelocytic leukaemia/retinoic acid receptor-alpha in promyelocytic leukaemia cells. Arsenic trioxide medac is a generic of Trisenox, which has been authorized in the European Union (EU) since 5 March 2002. Since arsenic trioxide medac is administered intravenously and is 100% bioavailable, a bioequivalence study versus the reference product was not required. The applicant for arsenic trioxide medac is medac Gesellschaft für klinische Spezialpräparate mbH.

EMA also adopted a positive opinion for the marketing authorization of fampridine Accord as a treatment to improve walking of adult patients with multiple sclerosis suffering from walking disability. Fampridine Accord will be available as 10 mg prolonged-release tablets. The active substance is fampridine, a potassium channel blocker. By blocking potassium channels, fampridine reduces the leakage of ionic current through these channels, prolonging repolarization and thus enhancing action potential formation in demyelinated axons and neurological function. This may cause more impulses to be conducted in the central nervous system. Fampridine Accord is a generic of Fampyra, which has been authorized in the EU since 20 July 2011. Studies have demonstrated the satisfactory quality of fampridine Accord and its bioequivalence to Fampyra.  The applicant for fampridine Accord is Accord Healthcare S.L.U.

The CHMP positive opinion for these two generic drugs will be considered by the European Commission (EC). Once approved, the EC will grant a centralized marketing authorization for Member States of the EU.

Related article
Generics applications under review by EMA – July 2020

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