Arsenic trioxide Accord

arsenic trioxide

Opinion

On 19 September 2019, 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 Accord, intended for the treatment of acute promyelocytic leukaemia (APL). The applicant for this medicinal product is Accord Healthcare S.L.U.

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

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

The full indication is:

“Arsenic trioxide 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 acute promyelocytic leukaemia (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.”

Key facts

Name
Arsenic trioxide Accord
Agency product number
EMEA/H/C/005175
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
19/09/2019
Company name
Accord Healthcare S.L.U.
Status
Positive
Application type
Initial authorisation

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