Cubist Pharmaceuticals, Inc. Reports Positive Outcome From FDA Anti-Infective Drugs Advisory Committee; PDUFA Date For FDA Review Of CUBICIN sNDA Is March 24th

LEXINGTON, Mass.--(BUSINESS WIRE)--March 6, 2006--Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) today reported that the Anti-Infective Drugs Advisory Committee (AIDAC) voted that there was substantial evidence of safety and efficacy of CUBICIN(R) (daptomycin for injection) in the treatment of S. aureus bacteremia and infective endocarditis. The data reviewed today were based on the Cubist landmark Phase 3 trial, in which CUBICIN as monotherapy at 6 mg/kg met co-primary end points for non-inferiority vs. dual therapy standard of care for the treatment of patients with S. aureus bacteremia and infective endocarditis. The AIDAC vote today is not binding on the Food and Drug Administration (FDA) decision for the CUBICIN sNDA.
MORE ON THIS TOPIC