The FDA grants priority review to products it believes represent a therapeutic advance over existing medicines. By granting priority review status to Cubicin, the FDA has established a target date to act on the filing by March 24, 2006.
Cubist submitted the application on September 26, 2005, requesting approval for a new indication at 6mg/kg for treatment of patients with bacteremia with known or suspected endocarditis caused by Staphylococcus aureus.
Cubicin was originally approved on September 12, 2003, at 4mg/kg intravenously once-daily for the treatment of complicated skin and skin structure infections caused by Gram-positive organisms, including both susceptible and resistant strains of S. aureus (MSSA and MRSA respectively).
“There is a high unmet need for alternative therapies for very sick patients with staphylococcus aureus bacteremia and infective endocarditis. We are very pleased with the FDA’s decision to grant priority review to our sNDA application, based on the precedent setting trial we completed earlier this year,” said Frank Tally, chief scientific officer of Cubist.