ARIAD Pharmaceuticals, Inc.
) share prices rose 35.5% on the positive opinion by the
Committee for Human Medicinal Products (CHMP) of the European
Medicines Agency (EMA) for the continued availability of the
company's marketed drug Iclusig in the EU.
ARIAD gained EU approval for Iclusig for a couple of
indications in Jul 2013. The first indication was the treatment
of chronic phase, accelerated phase or blast phase chronic
myeloid leukaemia (CML) in adults who do not respond to or cannot
tolerate Sprycel or Tasigna. It is also approved for patients in
whom Gleevec is not appropriate as a subsequent treatment. The
second indication covers the treatment of Philadelphia-chromosome
positive acute lymphoblastic leukaemia (Ph+ ALL) in adults
unresponsive to Sprycel. It also includes patients for whom
Gleevec is not clinically appropriate. Iclusig is also approved
for patients who have the T315I mutation.
The EMA has recommended on measures to help minimize the risk
of occlusive vascular events in patients taking Iclusig. These
(i) Patients with a history of heart attack should not use
Iclusig, unless the potential benefits of treatment are more than
the risks. (ii) Before starting Iclusig treatment, an assessment
of cardiovascular status of patients should be done. (iii) In the
treatment process hypertension should be controlled and doctors
should consider interrupting treatment if hypertension is not
controlled. (iv) Patients should be monitored for evidence of
vascular occlusion or thromboembolism, and treatment should be
interrupted immediately in the event of its occurance. (v) The
EMA plans to further review the risks/benefits associated with
Iclusig and may make additional recommendations on its usage.
On Oct 31, 2013, there was a temporary suspension of the
marketing and commercial distribution of Iclusig in the U.S due
to higher-than-expected incidence of blood clotting. The share
price fell more than 44% immediately after the news.
ARIAD carries a Zacks Rank #3 (Hold). Some better ranked
Jazz Pharmaceuticals Plc
Lannett Company, Inc.
). All these stocks carry a Zacks Rank #1 (Strong Buy).
ARIAD PHARMA (ARIA): Free Stock Analysis
ENANTA PHARMA (ENTA): Free Stock Analysis
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LANNETT INC (LCI): Free Stock Analysis Report
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