Shares of ARIAD Pharmaceuticals, Inc. (ARIA - Snapshot Report) have been on an uptrend ever since the U.S. Food and Drug Administration (FDA) decided to allow the company to resume selling its leukemia drug Iclusig in the U.S.
ARIAD will resume selling the therapy from mid-Jan 2014 under a modified prescribing and risk management plan approved by the FDA. We remind investors that in Oct 2013, ARIAD announced the temporary suspension of the marketing and commercial distribution of Iclusig in the U.S. following instruction from the FDA due to a higher-than-expected incidence of blood clotting and narrowing of blood vessels.
Iclusig is currently approved for the treatment of patients suffering from T315I-positive chronic myeloid leukemia (CML: chronic, accelerated or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). It is also approved to treat chronic, accelerated or blast phase CML or Ph+ ALL patients for whom no other tyrosine-kinase inhibitor therapy is approved. Iclusig was initially launched in the U.S. in Jan 2013.
ARIAD clarified that the objections raised by the FDA have been addressed leading to the regulatory body agreeing to the resumption of sales of the drug. We note that ARIAD shares had gone down earlier in the month on the news that European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) was conducting a further in-depth review of the risk/benefit profile of Iclusig.
Earlier, EU regulators had recommended that Iclusig could remain on the market though tough restrictions would be imposed for continued marketing of the product. We expect investor focus to remain on further updates on the drug from the EU. |
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