The FDA has responded to Vion pharmaceuticals’ (Vion) Special Protocol Assessment (SPA) request to evaluate the phase III randomised trial, HOVON AML 92, sponsored by the Dutch-Belgian Cooperative Group for Hematology Oncology (HOVON) of its lead product, Onrigin.
The company claims that the FDA raised concerns with the HOVON trial design as submitted regarding the primary endpoint and study regimen. The modifications requested by the FDA would require a new phase III trial at significant additional time and expense.
The phase III randomized trial in acute myeloid leukemia (AML) is in response to the FDA’s complete response letter to Vion’s New Drug Application (NDA) for Onrigin, requiring that a randomized trial be conducted to support the approval of Onrigin for the treatment of AML, said the company.
Reportedly, on December 17, 2009, Vion filed a voluntary petition for relief under Chapter 11 of the US Bankruptcy Code in the US Bankruptcy Court in the District of Delaware.