ARTICLE | Clinical News

Ceplene histamine dihydrochloride regulatory update

January 2, 2012 8:00 AM UTC

EpiCept said that "adequate" supplies of Ceplene histamine dihydrochloride are available despite the cancer drug's third-party manufacturer ceasing all manufacture and distribution of medicines from the drug's manufacturing site. The manufacturer, Ben Venue Laboratories Inc., made the decision after GMP "shortcomings" were identified last year at the site. EpiCept said no immediate shortage of Ceplene is expected. The drug has not been included in a recall issued by EMA's CHMP due to the shortcomings. The company also said no complaints or issues related to product quality have been reported for Ceplene. Additionally, EpiCept said it distributed a "Direct Healthcare Professional Communication" to alert professionals to examine each vial for particulates before use.

Ceplene is approved in the EU and Israel to maintain remission and prevent relapse in patients with acute myelogenous leukemia (AML) in first complete remission. Last year, FDA indicated EpiCept should compare Ceplene vs. IL-2 vs. IL-2 alone as part of a registration trial in order to isolate the effect of Ceplene from IL-2 (see BioCentury, Sept. 19, 2011). In 2010, FDA refused to file an NDA for Ceplene in combination with low dose IL-2 in the indication. The histamine receptor agonist has Orphan Drug designation in the U.S. for the indication. ...