FDA approves bactericidal antibiotic

The FDA has approved Cubist Pharmaceuticals', Cubicin (daptomycin for injection) for the treatment of complicated skin and skin structure (cSSS) infections caused by Gram-positive bacteria, including those caused by MRSA (methicillin-resistant Staphylococcus aureus) and MSSA (methicillin-susceptible S. aureus).

'The approval of Cubicin is particularly important as we face the growing public health crisis of bacterial resistance,' said Dr Robert A. Weinstein, chairman of the division of infectious diseases at Stroger Hospital of Cook County in Chicago and a Cubist scientific advisor. 'There has been a frightening increase in MRSA infections over the past decade, and the tools currently available to combat this problem have become less effective. The approval of Cubicin gives physicians a new weapon against cSSS infections, particularly to treat the estimated 600,000 U.S. patients who contract MRSA cSSS infections each year.'

Cubicin is an antibacterial agent from a new class of antibiotics called cyclic lipopeptides, and has clinical utility in the treatment of infections caused by aerobic Gram-positive bacteria. The in vitro spectrum of activity of Cubicin encompasses most clinically relevant Gram-positive pathogenic bacteria, including bacterial isolates resistant to methicillin, vancomycin and linezolid. In the U.S., MRSA now accounts for nearly 60% of staphylococcus infections in hospitals, and the incidence of MRSA in the community is on the rise as well.

Cubicin has been approved for intravenous administration at 4 mg/kg once-daily. 'With the approval of Cubicin today, Cubist joins an elite group of biopharmaceutical companies that have transitioned from discovery-based start-ups to operating companies,' said Michael W. Bonney, president and ceo of Cubist.