Gilead Sciences, Inc. has obtained data supporting bioequivalence of a formulation of the fixed-dose combination of Truvada (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals’ investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride, 25 mg). A bioequivalence study is required to demonstrate that a co-formulated product results in the same levels of medication in the blood as achieved when the individual products are dosed simultaneously as separate pills. Gilead anticipates submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the fixed-dose combination following validation of the TMC278 NDA.
Johnson & Johnson, which owns Tibotec Pharmaceuticals, announced that the two pivotal Phase 3 studies evaluating TMC278 as a treatment for HIV in treatment-naïve patients met the primary efficacy objective. In addition, the company announced plans to present the data in full at an upcoming HIV conference, and that submission of TMC278 for regulatory review is on track for the third quarter of this year.
The fixed-dose single-tablet combination of Truvada and TMC278 is an investigational product and the safety and efficacy have not yet been established.
Date: April 27, 2010
Source: Gilead Sciences, Inc.
Filed Under: Drug Discovery