ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the marketing authorization application for Iclusig™ (ponatinib) for two indications:
- The treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or
- The treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
“The positive recommendation by the CHMP of Iclusig for use in CML and Ph+ALL provides a broad indication statement for Iclusig in resistant and intolerant patients with Philadelphia positive leukaemias, including many patients who have failed only one prior tyrosine kinase inhibitor,” stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “We appreciate the substantial efforts of the CHMP in reaching this positive opinion so rapidly as a consequence of Iclusig’s accelerated assessment designation, and we look forward to the anticipated marketing authorization by the European Commission around mid-2013.”
Although Iclusig was studied in Ph+ ALL patients who were resistant or intolerant to dasatinib or nilotinib, nilotinib is not approved for the treatment of Ph+ ALL.
The CHMP granted ARIAD accelerated assessment for its review of the Iclusig marketing authorization application last summer. Accelerated assessment was introduced by the European Union in 2005. Its aim is to help speed access for patients to new medicines of major public-health interest. Companies can request accelerated assessment provided they are able to demonstrate that their product responds to an unmet medical need and is expected to have a major impact on medical practice.
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