Bioenvision Inc. has completed the substantive work and analysis involved with finalizing the Marketing Authorization Application (MAA) to expand the Evoltra (clofarabine) label and is now involved with the administrative aspects of formally submitting the filing to the European Medicines Agency (EMeA) for the use of Evoltra in adult AML patients over 65 years and who are considered unsuitable for intensive therapy.
The formal submission of the MAA is expected in the early part of Q1 2007. Bioenvision continues to expect a decision on this regulatory filing in calendar 2007.
"We are taking the appropriate steps to aggressively, but systematically, manage the valuable clofarabine franchise, which we believe has clinical applications in many forms of haematological malignancies and solid tumours and potentially autoimmune diseases," said Chris Wood, MD, chairman and CEO of Bioenvision. "As we announced at the ASH conference earlier this month, we are very pleased with the data that forms the basis of our pending Evoltra filing."
The European Marketing Authorization for Evoltra (clofarabine) is for "the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory to at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients less than or equal to 21 years old at initial diagnosis."
Clofarabine is in clinical development for the treatment of other haematological cancers and solid tumours. Bioenvision has conducted nonclinical studies of Evoltra for the treatment of psoriasis and is planning further worldwide development of Evoltra in autoimmune diseases.
Evoltra (clofarabine) is a next generation purine nucleoside analog. Bioenvision holds an exclusive worldwide license (excluding U.S. and Canada) for the cancer applications of clofarabine and an exclusive worldwide license for all non-cancer indications.