Adventrx Files New Drug Application For ANX-530

Adventrx Pharmaceuticals (Adventrx) has submitted a new drug application (NDA) to the FDA for its product candidate ANX-530 (vinorelbine injectable emulsion).

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 has 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. 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.

Brian Culley, principal executive officer of Adventrx, said: “ANX-530 has the potential to offer important benefits to cancer patients, and we look forward to working with FDA towards its approval. The ANX-530 NDA submission is a key step in our strategy to create valuable products that improve the performance of currently approved drugs.”