GlaxoSmithKline's retapamulin antibiotic NDA accepted for review by FDA

By Angela McDaniels

Seattle, Feb. 14 - GlaxoSmithKline plc said the Food and Drug Administration has begun the review process for its investigational antibiotic retapamulin.

GlaxoSmithKline submitted a New Drug Application for the product to the FDA in November and said it expects to receive approval to market the product later this year.

Retapamulin is the first in a new class of antibiotics called pleuromutilins and is designed for the topical treatment of uncomplicated skin and skin structure infections due to susceptible strains of Staphylococcus aureus and Streptococcus pyogenes. It has been studied for use twice a day over a five-day period.

The clinical trials for retapamulin involved 2,450 patients worldwide, and the New Drug Application is based on data from a phase 3 clinical trial of 712 patients in the United States.

According to a company news release, retapamulin shows a high degree of in vitro potency against key pathogens commonly associated with skin and skin structure infections, consistently shows potent activity when compared to other commonly prescribed topical and oral antimicrobial agents and demonstrated a low propensity for development of resistance in target pathogens during laboratory studies.

Additionally, it has shown no target-specific cross-resistance to other established classes of antibiotics during in vitro studies, the company said.

GlaxoSmithKline is a British pharmaceutical company with U.S. operations in Philadelphia and Research Triangle Park, N.C.

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