ARIAD Announces Final Decision from European Commission Endorsing Iclusig’s Approved Indications Throughout Europe
January 20 2015 - 7:35AM
Business Wire
Legally Binding Decision Follows
Recommendations of Pharmacovigilance Risk Assessment Committee
Review
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that
the European Commission (EC) has endorsed the final opinion adopted
by the Committee for Medicinal Products for Human Use (CHMP) on
Iclusig® (ponatinib) following recommendations made by the
Pharmacovigilance Risk Assessment Committee (PRAC). This concludes
the European Article 20 review of Iclusig and is a binding decision
for Iclusig to continue to be prescribed in Europe in accordance
with its already approved indications.
“With this final step in the review of Iclusig in Europe now
complete, we will continue to focus our efforts on completing
pricing and reimbursement in the remaining European countries this
year and ensuring that Iclusig is available to all appropriate
Philadelphia-chromosome positive leukaemia patients,” said Jonathan
E. Dickinson, general manager, ARIAD Pharmaceuticals (Europe).
“This thorough review validates Iclusig’s indications and the
favorable benefit-risk balance of Iclusig for patients with
resistant or intolerant CML.”
In October 2014, the PRAC concluded an 11-month review of the
available data on Iclusig after consultation with the EMA
scientific advisory group in oncology. The PRAC recommended that
the Iclusig indications remain unchanged and confirmed that the
benefit-risk profile of Iclusig was favorable in its approved
indications. This recommendation was endorsed by the CHMP at
European Medicines Agency (EMA). The EMA also recommended
additional warnings in the European product information to minimize
the risk of vascular events and introduce flexibility to reduce the
dose after achievement of response in patients with chronic phase
CML (CP-CML).
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.
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 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 management'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 the impact of the strengthened warnings
recommended by the CHMP on sales of Iclusig; difficulties in
commercializing Iclusig arising from the post-marketing approval
review process or from its results; the emergence of other 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
Sep;22(3):295-302. Based on current estimate of population of
Europe (738,199,000 in 2010).
ARIAD PharmaceuticalsFor 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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