Ariad Pharmaceuticals Inc.
) recently announced that its tyrosine kinase inhibitor (TKI),
Iclusig (ponatinib), has been granted marketing authorization in
the EU by the European Commission (EC). Iclusig gained EU
approval for two indications.
The first indication is the treatment of chronic phase,
accelerated phase or blast phase chronic myeloid leukemia (CML)
in adults who do not respond to or cannot tolerate Sprycel
(dasatinib) or Tasigna (nilotinib). It is also approved for
patients in whom Gleevec (imatinib) is not appropriate as a
subsequent treatment. The second indication covers the treatment
of Philadelphia-chromosome positive acute lymphoblastic leukemia
(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 most common serious adverse reactions found in Iclusig
were pancreatitis, abdominal pain, pyrexia, anemia, febrile
neutropenia, decrease in platelet count and neutrophil count,
pancytopenia, myocardial infarction, diarrhea, and increased
lipase. Meanwhile, the adverse reactions of any severity, which
were most common (≥20%), were decrease in platelet count, rash,
dry skin and abdominal pain.
EU approval was in line with expectations as the CHMP had
rendered a positive opinion in Mar 2013.
Ariad gained US Food and Drug Administration (FDA) approval in
Dec 2012 for Iclusig and launched it in Jan 2013. The drug gained
approval for treating adults suffering from chronic, accelerated
or blast phase chronic myeloid leukemia, and Philadelphia
chromosome-positive acute lymphoblastic leukemia, who are
resistant or intolerant to TKI therapy. Ariad recorded Iclusig
sales of $6.4 million in the first quarter of 2013.
Ariad currently carries a Zacks Rank #3 (Hold). At present,
Jazz Pharmaceuticals Public Limited Company
Salix Pharmaceuticals Ltd.
) look well positioned with a Zacks Rank #1 (Strong Buy).
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