GlaxoSmithKline's Altabax garners FDA approval

GlaxoSmithKline's Altabax (retapamulin) received FDA approval to treat impetigo due to susceptible strains of Staphylococcus aureus or Streptococcus pyogenes. The company indicated that the compound is the first in a new class of topical antibiotics to receive marketing authorisation in the US in nearly 20 years.

The approval was based on data from a Phase III study involving 210 patients with impetigo. After five days of treatment, 85.6 percent of patients who received the drug had no further need of treatment, compared to 52.1 percent in the placebo group.

UBS analyst David Beadle suggested that European regulators may also approve the drug in the coming months. Beadle forecast that the treatment could have annual sales of 148 million pounds ($294 million) by 2011, with about half its revenue being generated from the US.

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