Vion Pharmaceuticals, Inc. has announced that the New Drug Application (NDA) for its lead oncology therapeutic Onrigin (laromustine) Injection has been accepted for review by the U.S. Food and Drug Administration (FDA).
The Company had previously announced the filing of the NDA with the FDA in February 2009. The NDA presents data for Onrigin as a single agent for remission induction treatment for patients sixty years of age or older with de novo poor-risk acute myeloid leukemia (AML). The NDA is based on the results of an international multi-center pivotal Phase II trial of 85 patients sixty years of age or older with de novo poor-risk AML, supplemented by data from 55 patients in a previous Phase II trial in elderly AML. Eighty-six percent of these 140 patients had two or more risk factors that predicted for a poor prognosis.
Alan Kessman, Chief Executive Officer, commented, "Acceptance of our NDA filing for review is an important milestone for Vion. We will continue to work closely with the FDA on the filing with the objective of achieving approval for Onrigin in its first indication in the United States."