Cubicin was originally approved in September, 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 June of this year, Cubist announced that in a phase III study of infective endocarditis (inflammation of the membrane of the heart) and bacteremia (bacteria in the blood) caused by S aureus, CUBICIN at 6 mg/kg intravenously met both primary end points in the test.
“This filing addresses an unmet medical need. This sNDA is the first registration filing for S aureus bacteremia and infective endocarditis,” said Frank Tally, senior vice president and chief scientific officer.
Cubist has requested that the FDA consider granting this sNDA priority review status, which could shorten review time from the standard twelve months to six months. The FDA customarily accepts or refuses to file NDAs and designates review status within 60 days of filing.