Advantrx Pharmaceuticals, Inc has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its product candidate ANX-530 (vinorelbine injectable emulsion).
"I congratulate our development team for achieving this important milestone on schedule in December, as planned. ANX-530 has the potential to offer important benefits to cancer patients, and we look forward to working with FDA towards its approval," said Brian M Culley, principal executive officer of Adventrx. "The ANX-530 NDA submission is a key step in our strategy to create valuable products that improve the performance of currently approved drugs."
The company is seeking approval of ANX-530 for the same indications as Navelbine, a branded formulation of vinorelbine, including non-small cell lung cancer. Adventrx submitted the NDA as a 505(b)(2) application, which relies in part on the FDA's findings of safety and effectiveness of a reference drug. The company's 505(b)(2) NDA submission includes data from one clinical bioequivalence study designed to assess the pharmacokinetic equivalence of ANX 530 and Navelbine, the reference drug.
ANX-530 is Adventrx's proprietary emulsion formulation of vinorelbine. Vinorelbine is a vesicant and venous irritant, and these adverse effects can limit its tolerability. ANX-530 was designed to be bioequivalent to the reference drug while reducing the incidence and severity of vein irritation associated with intravenous delivery of the drug. In a clinical bioequivalence study, ANX 530 and the reference drug were determined to be bioequivalent.
Adventrx Pharma is a specialty pharmaceutical company whose product candidates are designed to improve the performance of existing cancer treatments by addressing limitations associated principally with their safety and use.