GSK RECEIVES APPROVABLE LETTER FOR TOPICAL ANTIBIOTIC

GlaxoSmithKline (GSK) announced that the FDA has issued an approvable letter for its topical antibacterial, Altabax (retapamulin ointment), 1 percent, for the treatment of secondarily infected traumatic lesions (SITL). SITL is a type of skin infection most commonly caused by Staphylococcus aureus and Streptococcus pyogenes.

In the letter, the FDA requested additional information to complete its assessment of Altabax as a treatment for SITL. No safety concerns were noted.

The FDA also notified GSK that it did not approve a second indication in the treatment of secondarily infected dermatoses (SID) contained in the same new drug application (NDA). The FDA will require additional clinical studies to consider approving Altabax as a treatment for SID.

A separate Altabax NDA for the treatment of impetigo is also currently being reviewed by the FDA. Impetigo is a superficial skin infection most commonly seen in children. The NDA for the impetigo indication is based primarily on the results of a double-blind, placebo-controlled clinical study demonstrating that the efficacy of Altabax was superior to placebo in adults and children. GSK expects to receive the FDA's decision for this indication in the second quarter of 2007.

Altabax belongs to a new class of antibiotics called pleuromutilins and demonstrates a unique mode of action that is different from currently available antibiotics, according to GSK. The drug exhibits a low potential for the development of resistance.