EMA Continues Review Of Ariad's Iclusig In EU
Ariad Pharmaceuticals announced that the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is continuing its review of cancer drug Iclusig and has issued a request for limited additional information under the Article 20 referral procedure.
Iclusig (ponatinib) is a kinase inhibitor primarily targeting BCR-ABL, an abnormal tyrosine kinase expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). The drug is approved in the EU for the treatment of specific cases of CML and Ph+ALL. However the PRAC has launched an in-depth review of Iclusig following adverse events reports of serious blood clot and toxicity risks during treatment. The U.S. Food and Drug Administration (FDA) also ordered a temporary sales ban of the drug in the U.S. in October 2013, as well as a clinical hold on pending Phase II and III studies of Iclusig in other indications. Iclusig has been since allowed back on the market in the U.S. following the addition of a more detailed warning label.
In view of the regulatory woes blighting its sole product, many considered the biotech firm at the end of its rope. Indeed, the company let go of 40 percent of its U.S. workforce to salvage its European workforce and save $26 million. At the time, some thought it best for Ariad to seek a lifesaving partnership or put up its whole setup for sale or acquisition. However, the company is pushing on to recover its footing on lost ground over Iclusig.
The company said that with its response to additional information requests and input from the agency’s Scientific Advisory Group, it anticipates the PRAC to make a final recommendation to the EMA’s Committee for Medicinal Products for Human Use (CHMP) by October of this year.
Timothy P. Clackson, President of R&D and CSO at Ariad, said, “As we finalize our recommendations on dose modifications of Iclusig and response monitoring of patients, we will work closely with the European regulatory agency and its expert advisors so that CML patients and their treating physicians have the best guidance available supporting the appropriate use of Iclusig.”