Arsenic trioxide medac

arsenic trioxide

Table of contents

Opinion

On 23 July 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product 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 acute promyelocytic leukaemia (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 Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha (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 (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Key facts

Name
Arsenic trioxide medac
Agency product number
EMEA/H/C/005218
International non-proprietary name (INN) or common name
  • arsenic trioxide
Active substance
  • Arsenic trioxide
Therapeutic area
Leukemia, Promyelocytic, Acute
Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Date opinion adopted
23/07/2020
Company name
medac Gesellschaft für klinische Spezialpräparate mbH
Status
Positive
Application type
Initial authorisation

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