ARIAD Pharmaceuticals, Inc. 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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