Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

EMA Recommends Granting a Marketing Authorisation for Generic Arsenic Trioxide

Arsenic trioxide medac is a generic of Trisenox which has been authorised in the EU since 2002
10 Aug 2020
Anticancer agents & Biologic therapy;  Haematologic malignancies

On 23 July 2020, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product arsenic trioxide (Arsenic trioxide medac), intended for the treatment of acute promyelocytic leukaemia (APL).

The applicant for this medicinal product is medac Gesellschaft für klinische Spezialpräparate mbH.

Arsenic trioxide medac will be available as 1 mg/ml concentrate for solution for infusion. The active substance of Arsenic trioxide medac is arsenic trioxide, an antineoplastic agent (ATC code: L01XX27). The mechanism of action of arsenic trioxide is not completely understood but it causes fragmentation, damage or degradation of DNA and the fusion protein pro-myelocytic leukaemia/retinoic acid receptor-alpha (PML/RAR-alpha) in promyelocytic leukaemia cells.

Arsenic trioxide medac is a generic of Trisenox, which has been authorised in the EU since 5 March 2002. Since Arsenic trioxide medac is administered intravenously and is 100% bioavailable, a bioequivalence study versus the reference product Trisenox was not required.

The full indication is:

Arsenic trioxide medac is indicated for induction of remission, and consolidation in adult patients with:

  • Newly diagnosed low-to-intermediate risk APL (white blood cell count, ≤10 x 10³/µl) in combination with all-trans-retinoic acid (ATRA)
  • Relapsed/refractory APL (previous treatment should have included a retinoid and chemotherapy)

characterised by the presence of the t(15;17) translocation and/or the presence of the PML/RAR-alpha gene.

The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.

Arsenic trioxide medac should be prescribed by physicians experienced in the treatment of acute leukaemias.

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the European Commission decision, which will normally be issued 67 days from adoption of the opinion.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings