GlaxoSmithKline antibiotic goes to FDA review

The US Food and Drug Administration (FDA) has begun its review of GlaxoSmithKline’s (GSK) investigational antibacterial retapamulin.

GSK submitted a new drug application (NDA) for retapamulin in November last year and expects to receive approval later this year.

Retapamulin was developed as a treatment for skin and skin structure infections due to susceptible strains of Staphylococcus aureus and Streptococcus pyogenes.

A GSK spokesman explained the importance of the new antibiotic.

He said: “Continued widespread use of antibiotics has promoted the spread of antibiotic resistance and has created an urgent need for antibacterial agents with no known cross-resistance.”

It was explained that retapamulin, the first in a new class of antibiotics called pleuromutilins, is unique in how it works by binding to a particular site of a bacteria and it has so far shown no target-specific cross-resistance to other established classes of antibiotics.

The NDA is based on clinical trials of over 700 US patients.

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