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Ariad's Iclusig Approved in EU - Analyst Blog

By: Zacks.com
Posted: 7/5/2013 6:37:00 PM
Referenced Stocks: ARIA;EC;JAZZ;SLXP;SNTS

Ariad Pharmaceuticals Inc. ( ARIA ) 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, companies like Jazz Pharmaceuticals Public Limited Company ( JAZZ ), Santarus, Inc. ( SNTS ) and Salix Pharmaceuticals Ltd. ( SLXP ) look well positioned with a Zacks Rank #1 (Strong Buy).



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