FDA Panel Backs Cubist's Antibiotic Sivextr

(RTTNews) - Cubist Pharmaceuticals, Inc. (CBST) said Monday that the U.S. Food and Drug Administration Anti-Infective Drugs Advisory Committee has voted to recommend approval of the company's investigational antibiotic Sivextro.

In the unanimous 14 - 0 decision, the Committee found that substantial evidence of the safety and effectiveness of Sivextro for the treatment of acute bacterial skin and skin structure infections was provided.

Sivextro is a once daily oxazolidinone being developed for both intravenous and oral administration for the treatment of serious infections caused by certain Gram-positive bacteria, including those caused by methicillin-resistant Staphylococcus aureus.

The company's New Drug Application submission to the FDA for Sivextro is based on positive data from two global Phase 3 clinical studies, which met the primary and secondary endpoints defined by the FDA and European Medicines Agency.

The Committee's recommendation is not binding on the FDA, but will help inform the FDA as it completes its Priority Review of the NDA for Sivextro, which has an assigned action date of June 20.