Cubist Pharmaceuticals, Inc. announced that the US FDA has approved the supplemental new drug application (sNDA) for Cubicin (daptomycin for injection) as once-a-day therapy at 6 mg/kg for the treatment of Staphylococcus aureus (S. aureus) bloodstream infections (bacteremia) including right-sided endocarditis caused by MSSA (methicillin-susceptible S. aureus) and MRSA (methicillin-resistant S. aureus). Cubicin will be the only IV antibiotic approved for this indication based on the results of a prospective, randomized, controlled registration trial.
Cubist will commence marketing of Cubicin for the new indication immediately to acute care infectious disease doctors and specialists who treat S. aureus bloodstream infections, a company release said.
The FDA decision follows the positive recommendations of the Anti-infective Drugs Advisory Committee, which at its March 6th meeting reviewed data from a landmark phase 3 trial conducted by Cubist, a study of the efficacy and safety of Cubicin at 6 mg /kg once-a-day as monotherapy vs 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.
Mike Bonney, president and CEO of Cubist said, "I'm very proud of the team that conceived, conducted, and presented this historic study to the FDA. I am also thankful to the infectious disease experts and FDA scientists who worked with us, the investigators at 76 sites in the US and Europe, and the patients who were treated as part of the clinical trial. The approval received today provides the clinicians who treat these complicated infections with an alternative therapy backed by prospectively collected, controlled, and comparative clinical data."
Dr. Ralph Corey said, "Doctors who treat patients with bloodstream infections caused by S. aureus, particularly for infections caused by MRSA, need alternative therapies. The "Bad Bugs/No Drugs" initiative of the Infectious Disease Society of America has identified MRSA as one of six top priority, dangerous, drug resistant microbes. The FDA approval of Cubicin for the treatment of these complicated, and life threatening infections is good news." Dr. Corey is professor of medicine and infectious disease at Duke University Medical Centre and director of infectious disease at Duke Clinical Research Institute. Dr. Corey chaired the Independent External Adjudication Committee (IEAC) which, blinded to therapy, assessed outcomes for all patients in the phase 3 trial.
Cubicin was originally approved on September 12, 2003, at 4 mg/kg intravenously once daily for the treatment of complicated skin and skin structure infections (cSSSI) caused by Gram-positive organisms, including both susceptible and resistant strains of S. aureus (MSSA and MRSA respectively). In September of 2005, Cubist submitted to the FDA a sNDA for an expanded label. The file was accepted and given Priority Review designation by the FDA on November 25th, followed by an FDA Approvable Letter on March 24th. The phase 3 trial results showed that, for the treatment of S. aureus bacteremia and endocarditis, Cubicin at 6 mg/kg intravenously once daily met both primary end points for non-inferiority vs. comparator consisting of dual therapy (semi synthetic penicillin plus initial gentamicin for infections caused by MSSA or vancomycin plus initial gentamicin for infections caused by MRSA).
US Patent No. 6,468,967 provides US market exclusivity for the once-daily administration of Cubicin until 2019.