ARIAD
Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced adoption of a
positive opinion by the Committee for Human Medicinal Products (CHMP) of
the European Medicines Agency (EMA) on the continued availability of
Iclusig® (ponatinib) in the EU for use in patients in its
authorized indications. Following its review of updated clinical-trial
data on Iclusig, the CHMP made a series of recommendations on measures
to help minimize the risk of occlusive vascular events in patients
taking Iclusig. The authorized indications of Iclusig, 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.
The EMA has recommended the following:
-
Iclusig should not be used in patients with a history of heart attack
or stroke, unless the potential benefits of treatment outweigh the
risks.
-
The cardiovascular status of patients should be assessed and
cardiovascular risk factors actively managed before starting treatment
with Iclusig. Cardiovascular status should continue to be monitored
and optimised during treatment.
-
Hypertension should be controlled during treatment with Iclusig, and
healthcare professionals should consider interrupting treatment if
hypertension is not controlled.
-
Patients should be monitored for evidence of vascular occlusion or
thromboembolism, and treatment should be interrupted immediately if
this occurs.
The EMA plans to conduct a further review of the benefits and risks of
Iclusig and may make additional recommendations on how Iclusig should be
used.
“We have been working closely with the EMA to provide updated
clinical-trial data on patients treated with Iclusig,” said Jonathan E.
Dickinson, general manager, ARIAD Pharmaceuticals (Europe). “The
conclusions reached by the CHMP, which were announced today, confirm a
positive benefit-risk assessment for Iclusig after considering the most
recent safety information. We expect that this will provide helpful
guidance for patients and healthcare professionals as they consider the
treatment options.”
The CHMP is a scientific committee composed of representatives from the
28-member states of the EU, and Iceland and Norway. The CHMP reviews
medical product applications on their scientific and clinical merit and
provides advice to the European Commission, which has the authority to
approve medicines for the EU.
CML is a cancer of the white blood cells that is diagnosed in
approximately 7,000 patients each year in Europe[1]. CML and
Ph+ ALL patients treated with tyrosine kinase inhibitors (TKIs) can
develop resistance or intolerance over time to these therapies. Iclusig
is a targeted cancer medicine discovered and developed at ARIAD. It was
designed by ARIAD scientists using ARIAD’s platform of computational
chemistry and structure-based drug design to inhibit BCR-ABL, including
drug-resistant mutants that arise during treatment. Iclusig is the only
TKI that has been approved/received a marketing authorisation for an
indication that includes CML and Ph+ ALL patients with the T315I
mutation.
About CML and Ph+ ALL
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, a decision by
the European Commission not to adopt the recommendation of the CHMP or
to adopt the recommendation but with revisions affecting the Company’s
ability to successfully launch, commercialize and generate profits from
sales of Iclusig; 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.
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).
Copyright Business Wire 2013