FDA OKs expanded label for Cubist's Cubicin

The US Food and Drug Administration has approved Cubist Pharmaceuticals' supplemental new drug application for Cubicin (daptomycin for injection) as once-a-day therapy at 6mg/kg for the treatment of Staphylococcus aureus bloodstream infections (bacteremia) including right-sided endocarditis caused by methicillin-susceptible S aureus and methicillin-resistant S aureus.

Cubist estimates that these infections account for 30,000 deaths in the USA alone each year. Cubicin will be the only intravenous antibiotic approved for this indication based on the results of a prospective, randomized, controlled registration trial. The company says it will commence marketing the product for the new indication immediately to acute care infectious disease doctors and specialists who treat S aureus bloodstream infections.

The FDA decision follows the positive recommendations of the Anti-infective Drugs Advisory Committee which, at its March 6 meeting, reviewed data from a landmark Phase III trial conducted by Cubist. This was a study of the efficacy and safety of Cubicin at 6mg/kg once-a-day as monotherapy versus dual therapy standard-of-care therapy (semi-synthetic penicillin plus initial gentamicin for infections caused by MSSA or vancomycin plus initial gentamicin for infections caused by MRSA) for the treatment of S aureus bacteremia and endocarditis.