ADVENTRX Pharmaceuticals, Inc. and the 505(b)(2) New Drug Application (NDA) for ANX-530

tim — Mon, 18 Jan 2010 02:29:28 +0000

There has certainly been a lot of attention paid to ADVENTRX Pharmaceuticals over the past few days so it comes as no surprise that we have had a lot of questions concerning this company’s use of a 505(b)(2) New Drug Application (NDA) for ANX-530. This NDA is different from a full NDA (the usual for a new drug) and different from an ANDA (which is used for generic drugs). The FDA defines a 505(b)(2) application as: “…one for which one or more of the investigations relied upon by the applicant for approval were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted”. It basically allows a company (like ADVENTRX) to ask the FDA for approval of its proprietary formulation of vinorelbine (ANX-530 – vinorelbine emulsion) based partly on safety and effectiveness data generated in the approval of a reference drug, which in this case is Navelbine® (vinorelbine). In its January 10, 2010 press release ADVENTRX states that it is seeking approval for the same indications as Navelbine® including non-small cell lung cancer. The company states that the 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. As such, the position of ADVENTRX would be that the data required by the FDA for approval can be adequately obtained through a small clinical trial (30 patients or so) relatively quickly and inexpensively compared to the phase I, phase II and phase III clinical trials required to support a full NDA. ADVENTRX believes that by delivering intravenous vinorelbine as an emulsion, ANX-530 can reduce the incidence and severity of vein irritation that may be associated with the administration of this chemotherapeutic agent.

BioHorizon » Navelbine

ADVENTRX Pharmaceuticals, Inc. and the 505(b)(2) New Drug Application (NDA) for ANX-530