ARIAD Pharmaceuticals, Inc. (ARIA) announced that the European Commission (EC) has sanctioned the Committee for Medicinal Products for Human Use’s (CHMP) recommendation regarding the use of Iclusig in its approved indications. With this endorsement, the European Article 20 review of Iclusig is complete.
ARIAD said that following the review, the original indications for Iclusig will remain unchanged. The drug is approved for two indications in Europe – firstly, chronic, accelerated or blast phase chronic myeloid leukaemia (CML) in patients who are resistant or intolerant to Sprycel or Tasigna and inappropriate for subsequent treatment with Gleevec or patients with T315I mutation and secondly, Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) in patients who are resistant or intolerant to Sprycel and inappropriate for subsequent treatment with Gleevec or patients with T315I mutation.
We remind investors that the European Medicines Agency (EMA) had launched an in-depth review in 2013 to assess the benefits-risk profile of Iclusig for better understanding its nature, frequency and severity in obstructing the veins or arteries and the mechanism that leads to such side effects. In Oct 2014, the Pharmacovigilance Risk Assessment Committee confirmed on the basis of an 11-month review of the available data on Iclusig that the benefit-risk profile of the drug was favorable in the indications which it was already approved for. This was followed by a recommendation by the CHMP toward the use of Iclusig in its approved indications. However, with this recommendation, the EMA suggested additional warnings in the European product information pertaining to the minimization of the risks associated with vascular events and the introduction of flexibility in dosage reduction upon the achievement of response in chronic phase CML patients.
The EC’s final, legally binding decision on Iclusig has validated the indications for which the drug is approved, fortifying its position in the CML market. With almost 7,000 patients suffering from CML in Europe every year (according to an abstract published in Best Practice & Research Clinical Haematology), we believe Iclusig has a good scope of gaining a high market share. In the first nine months of 2014, Iclusig generated revenues of $34.4 million (following the re-launch of the drug on Jan 20, 2014 after a temporary suspension from Oct 2013).
We are pleased with the EC’s decision to allow the sale of Iclusig for the approved indications. This has helped to remove an overhang on the benefit-risk aspect of the drug’s usage.
ARIAD carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Endo International plc (ENDP), Biodel Inc. (BIOD) and BioLineRx, Ltd. (BLRX). All these stocks carry a Zacks Rank #1 (Strong Buy).
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