The Anti-Infective Drugs Advisory Committee (AIDAC) voted that there was substantial evidence of safety and efficacy of Cubicin (daptomycin for injection) in the treatment of S. aureus bacteremia and infective endocarditis.
The data reviewed were based on Cubist’s landmark phase III trial, in which Cubicin as monotherapy at 6mg/kg met co-primary end points for non-inferiority versus dual therapy standard of care for the treatment of patients with S. aureus bacteremia and infective endocarditis.
Cubist submitted the Cubicin supplemental new drug application (sNDA) 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 S. aureus. On November 21, 2005 Cubist announced that it had received notice from the FDA that the sNDA had been accepted and granted priority review status. In granting priority review status to Cubicin, the FDA established a target date (also known as a PDUFA date) to act on the sNDA filing by March 24, 2006.
“As the trial data reviewed with the Advisory Committee demonstrate, patients with infections of the bloodstream and heart caused by S. aureus are seriously ill and pose treatment challenges. These challenges are particularly significant when the infection is caused by methicillin resistant S. aureus, or MRSA. Cubicin, if approved for an expanded label, can offer physicians a much-needed therapeutic alternative for patients with these serious infections,” commented Dr Ralph Corey, professor of medicine and infectious disease at Duke University Medical Center.