Legally Binding Decision Follows Recommendations of Pharmacovigilance Risk Assessment Committee Review
CAMBRIDGE, Mass. & LAUSANNE, Switzerland--(BUSINESS WIRE)-- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that the European Commission (EC) has endorsed the final opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) on Iclusig® (ponatinib) following recommendations made by the Pharmacovigilance Risk Assessment Committee (PRAC). This concludes the European Article 20 review of Iclusig and is a binding decision for Iclusig to continue to be prescribed in Europe in accordance with its already approved indications.
"With this final step in the review of Iclusig in Europe now complete, we will continue to focus our efforts on completing pricing and reimbursement in the remaining European countries this year and ensuring that Iclusig is available to all appropriate Philadelphia-chromosome positive leukaemia patients," said Jonathan E. Dickinson, general manager, ARIAD Pharmaceuticals (Europe). "This thorough review validates Iclusig's indications and the favorable benefit-risk balance of Iclusig for patients with resistant or intolerant CML."
In October 2014, the PRAC concluded an 11-month review of the available data on Iclusig after consultation with the EMA scientific advisory group in oncology. The PRAC recommended that the Iclusig indications remain unchanged and confirmed that the benefit-risk profile of Iclusig was favorable in its approved indications. This recommendation was endorsed by the CHMP at European Medicines Agency (EMA). The EMA also recommended additional warnings in the European product information to minimize the risk of vascular events and introduce flexibility to reduce the dose after achievement of response in patients with chronic phase CML (CP-CML).
The authorized indications of Iclusig in Europe, as approved in July 2013, are as follows:
About CML and Ph+ ALL
CML is a cancer of the white blood cells that is diagnosed in approximately 7,000 patients each year in Europe . CML is characterized by an excessive and unregulated production of white blood cells by the bone marrow due to a genetic abnormality that produces the BCR-ABL protein. After a chronic phase of production of too many white blood cells, CML typically evolves to the more aggressive phases referred to as accelerated phase and blast crisis. Ph+ ALL is a subtype of acute lymphoblastic leukaemia that carries the Ph+ chromosome that produces BCR-ABL. It has a more aggressive course than CML and is often treated with a combination of chemotherapy and tyrosine kinase inhibitors. The BCR-ABL protein is expressed in both of these diseases.
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts and Lausanne, Switzerland, is an integrated global oncology company focused on transforming the lives of cancer patients with breakthrough medicines. ARIAD is working on new medicines to advance the treatment of various forms of chronic and acute leukemia, lung cancer and other difficult-to-treat cancers. ARIAD utilizes computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines. For additional information, visit http://www.ariad.com or follow ARIAD on Twitter (@ARIADPharm).
This press release contains "forward-looking statements" including, but not limited to, updates on regulatory developments in Europe. Forward-looking statements are based on management's expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to the impact of the strengthened warnings recommended by the CHMP on sales of Iclusig; difficulties in commercializing Iclusig arising from the post-marketing approval review process or from its results; the emergence of other safety concerns based on additional adverse events in patients being treated with Iclusig and other risk factors detailed in the Company's public filings with the U.S. Securities and Exchange Commission. The information contained in this press release is believed to be current as of the date of original issue. The Company does not intend to update any of the forward-looking statements after the date of this document to conform these statements to actual results or to changes in the Company's expectations, except as required by law.
Iclusig® is a registered trademark of ARIAD Pharmaceuticals, Inc.
1. Rohrbacher M, Hasford J. Epidemiology of chronic myeloid leukaemia (CML). Best Pract Res Clin Haematol. 2009 Sep;22(3):295-302. Based on current estimate of population of Europe (738,199,000 in 2010).
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Source: ARIAD Pharmaceuticals, Inc.
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