ARIAD Announces Recommendation for Iclusig by the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency
October 10 2014 - 7:44AM
Business Wire
PRAC Recommends No Change to Approved
Indication in Europe
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that
the Pharmacovigilance Risk Assessment Committee (PRAC) of the
European Medicines Agency (EMA) has concluded its review of
Iclusig® (ponatinib) under the Article 20 referral procedure and
has recommended that Iclusig continue to be used in Europe in
accordance with its already approved indications.
“We are grateful for the rigorous and in-depth review provided
by the PRAC and the Scientific Advisory Group for Oncology,” stated
Harvey J. Berger, M.D., chairman and chief executive officer of
ARIAD. “The PRAC recommendation provides insightful guidance to
healthcare professionals and patients regarding the use of Iclusig
in patients with Ph+ leukemias and importantly, leaves the original
Iclusig indication statement unchanged. We look forward to
consideration and adoption of these recommendations by the CHMP
later this month and authorization by the European Commission by
the end of the year.”
The authorized indications of Iclusig in Europe, as approved in
July 2013, are as follows:
- 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.
Other recommendations made by the PRAC related to the Iclusig
Summary of Medicinal Product Characteristics (SmPC) include, (1)
patient monitoring for response according to standard clinical
guidelines, (2) consideration of Iclusig dose-reduction following
achievement of major cytogenetic response with subsequent
monitoring of response and, (3) consideration of Iclusig
discontinuation if a complete haematologic response has not been
achieved by three months. Further information is provided
indicating that the risk of vascular occlusive events is likely
dose-related. An update of the Warning and Precautions and
Undesirable Effects sections is also provided for inclusion in the
Iclusig SmPC.
“The recommendation from the PRAC confirms a positive
benefit-risk assessment for Iclusig after thorough consideration of
updated safety information,” said Stephen G. O’Brien, M.D., Ph.D.,
Professor of Haematology at the Northern Institute for Cancer
Research at Newcastle University, United Kingdom. “This is a good
outcome for patients and healthcare professionals in Europe as it
continues to offer a treatment option to CML patients who have
become resistant to, or intolerant of, certain other TKIs.”
The PRAC is the committee at the EMA that is responsible for
assessing and monitoring safety issues for human medicines. The
PRAC's recommendations are considered by the CHMP when it adopts
opinions for centrally authorized medicines and referral
procedures.
About CML and Ph+ ALL
CML is a cancer of the white blood cells that is diagnosed in
approximately 7,000 patients each year in Europe[1]. CML is
characterized by an excessive and unregulated production of white
blood cells by the bone marrow due to a genetic abnormality that
produces the BCR-ABL protein. After a chronic phase of production
of too many white blood cells, CML typically evolves to the more
aggressive phases referred to as accelerated phase and blast
crisis. Ph+ ALL is a subtype of acute lymphoblastic leukaemia that
carries the Ph+ chromosome that produces BCR-ABL. It has a more
aggressive course than CML and is often treated with a combination
of chemotherapy and tyrosine kinase inhibitors. The BCR-ABL protein
is expressed in both of these diseases.
About Iclusig® (ponatinib)
Iclusig is a kinase inhibitor. The primary target for Iclusig is
BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic
myeloid leukemia (CML) and Philadelphia-chromosome positive acute
lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using
ARIAD’s computational and structure-based drug design platform
specifically to inhibit the activity of BCR-ABL. Iclusig targets
not only native BCR-ABL but also its isoforms that carry mutations
that confer resistance to treatment, including the T315I mutation,
which has been associated with resistance to other approved
TKIs.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts and Lausanne, Switzerland, is an integrated global
oncology company focused on transforming the lives of cancer
patients with breakthrough medicines. ARIAD is working on new
medicines to advance the treatment of various forms of chronic and
acute leukemia, lung cancer and other difficult-to-treat cancers.
ARIAD utilizes computational and structural approaches to design
small-molecule drugs that overcome resistance to existing cancer
medicines. For additional information, visit
http://www.ariad.com or follow ARIAD on Twitter
(@ARIADPharm).
This press release contains “forward-looking statements”
including, but not limited to, updates on regulatory developments
in Europe. Forward-looking statements are based on the Company’s
expectations and are subject to certain factors, risks and
uncertainties that may cause actual results, outcome of events,
timing and performance to differ materially from those expressed or
implied by such statements. These risks and uncertainties include,
but are not limited to, a potential decision by the CHMP not to
adopt the recommendations of the PRAC or the European Commission
not to adopt the recommendation of the CHMP, or, in either case, to
adopt the recommendation but with revisions affecting the Company’s
ability to successfully commercialize and generate profits from
sales of Iclusig; difficulties in commercializing Iclusig arising
from the post-marketing approval review process or from its
results; the emergence of new safety concerns based on additional
adverse events in patients being treated with Iclusig and other
risk factors detailed in the Company's public filings with the U.S.
Securities and Exchange Commission. The information contained in
this press release is believed to be current as of the date of
original issue. The Company does not intend to update any of the
forward-looking statements after the date of this document to
conform these statements to actual results or to changes in the
Company's expectations, except as required by law.
Iclusig® is a registered trademark of ARIAD Pharmaceuticals,
Inc.
Reference:
1. Rohrbacher M, Hasford J. Epidemiology of
chronic myeloid leukaemia (CML). Best Pract Res Clin Haematol. 2009
Sept;22(3):295-302. Based on current estimate of population of
Europe (738,199,000 in 2010).
ARIAD Pharmaceuticals, Inc.For InvestorsKendra Adams,
617-503-7028Kendra.adams@ariad.comorFor U.S. MediaLiza
Heapes, 617-621-2315liza.heapes@ariad.comorFor EU MediaGemma
White, +44 (0)20 337 25 221gwhite@biosector2.co.uk
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