In the company’s news yesterday,
EpiCept Corp. announced the European Commission has granted the company full marketing authorization in 27 member states in the European Union, as well as Iceland, Leichtenstein and Norway. This is especially good news for the company, according to geographical statistics. Approximately 40,000 patients in the EU suffer from AML; about 16,000 new cases are diagnosed each year.
“Today marks a significant and welcome milestone for patients suffering from AML,” Jack Talley, president and CEO of EpiCept stated in the press release. “Ceplene is now the first approved therapy demonstrated to produce a clear benefit in prolonging leukemia-free survival and preventing relapse among AML patients. We are proud that this new therapeutic option will be available to physicians and patients in 30 countries.”
According to the press release, the European Commission based its approval on the results of EpiCept’s phase III trial for Ceplene used with IL-2, which showed more than 50 percent efficacy in reducing the occurrence of relapse in AML patients.
“The main challenge in AML treatment is to protect patients in their first complete remission from relapse, as a first relapse is associated with poor long-term survival. The combination of Ceplene and IL-2 has been demonstrated to be a safe therapy that improves leukemia-free survival by significantly reducing the risk of recurrent leukemia. Therefore, the approval granted for Ceplene is an important step forward in making the treatment available to AML patients,” Mats Brune, M.D., associate professor at Sahlgrenska University and principal investigator of the Ceplene phase III clinical trial stated.
EpiCept has been granted 10 years of exclusive marketing of Ceplene in the EU. The company will conduct two post-approval clinical studies to further study the treatment and has taken steps to get approval for Ceplene in North America.
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