Meda debuts leukemia drug Ceplene in the UK

A new drug that prevents relapse long term - and maintains remission of people with acute myeloid leukemia (AML) - has been launched in the UK by Meda Pharmaceuticals, which has licensed the product from the USA’s EpiCept.

In conjunction with the launch program, Meda has released new clinical trial data showing that the product, Ceplene (histamine dihydrochloride), prolongs remission and prevents relapse in patients under the age of 60. Ceplene has been shown to avert an additional 20% of relapses during the three years after chemotherapy.

Ceplene was approved by the European Medicines Agency (EMA) in 2008, but has yet to be cleared in the USA, where the Food and Drug Administration, as recently as last summer, refused to accept EpiCept’s New Drug Application for the drug, concluded that the application did not establish the drug's therapeutic contribution in its combination with interleukin-2, and recommended that an additional confirmatory pivotal trial assessing Ceplene's contribution and using overall survival as a primary endpoint be conducted (The Pharma Letter August 24, 2010).