AstraZeneca has won approval in the USA for a new use for Merrem (meropenem for injection), its broad-spectrum antibiotic.
The US Food and Drug Administration yesterday cleared the drug to treat adults and children with complicated skin and skin structure infections. At the moment, Merrem is available in the USA as a single agent therapy for intra-abdominal infections and bacterial meningitis.
The approval is based on results from one of the largest studies conducted to date of hospitalised patients with cSSSI. The study showed that Merrem was an effective treatment for this type of infection, even in hard-to-treat populations such as the elderly and patients with diabetes. Approximately 1.5 million patients in the US receive broad- spectrum antibiotics in hospitals for cSSSI each year.
Merrem is the leading drug in AstraZeneca’s anti-infectives portfolio, achieving first quarter 2005 sales of $131 million dollars, a rise of 35% [[28/04/05a]]. Analysts said the new indication, while a useful addition to the label, would not add significantly to the product’s sales momentum.