SOUTH SAN FRANCISCO, CA and DEERFIELD, IL, Nov. 5, 2009 (Marketwire) --
SOUTH SAN FRANCISCO, CA and DEERFIELD, IL -- (Marketwire) -- 11/05/09 -- Theravance, Inc. (NASDAQ: THRX) and Astellas Pharma US, Inc. announced today the commercial launch of VIBATIV(TM) (telavancin) in the United States. On September 11, 2009, the U.S. Food and Drug Administration (FDA) approved VIBATIV for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains. VIBATIV is a bactericidal, once-daily injectable lipoglycopeptide antibiotic discovered by Theravance.
"The availability of VIBATIV is wonderful news for clinicians treating MRSA infections," said Dr. Robert C. Moellering, Jr., Shields Warren-Mallinckrodt Professor of Medical Research at Harvard Medical School and Emeritus Physician-in-Chief and Chairman of the Department of Medicine at Beth Israel Deaconess Medical Center. "With the launch of VIBATIV, physicians now have an important and welcome addition to the current armamentarium for the treatment of cSSSI. We desperately need new antimicrobial agents to bridge the therapeutic gap created by increasingly resistant microbes. VIBATIV is specifically designed to solve this problem among resistant Gram-positive bacteria such as MRSA."
About VIBATIV
VIBATIV was discovered by Theravance in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus and other Gram-positive bacteria, including MRSA. VIBATIV is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with a dual mechanism of action whereby VIBATIV both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. VIBATIV is indicated for the treatment of adult patients with cSSSI caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius and S. constellatus) and Enterococcus faecalis (vancomycin-susceptible isolates only).
Important Safety Information
Fetal Risk
Women of childbearing potential should have a serum pregnancy test prior to administration of VIBATIV. Avoid use of VIBATIV during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus. Adverse developmental outcomes observed in three animal species at clinically relevant doses raise concerns about potential adverse developmental outcomes in humans. If not already pregnant, women of childbearing potential should use effective contraception during VIBATIV treatment.
Nephrotoxicity
New onset or worsening renal impairment occurred in patients who received VIBATIV. Renal adverse events were more likely to occur in patients with baseline comorbidities known to predispose patients to kidney dysfunction and in patients who received concomitant medications known to affect kidney function. Monitor renal function in all patients receiving VIBATIV prior to initiation of treatment, during treatment, and at the end of therapy. If renal function decreases, the benefit of continuing VIBATIV versus discontinuing and initiating therapy with an alternative agent should be assessed. Clinical cure rates in telavancin-treated patients were lower in patients with baseline CrCl less than or equal to 50 mL/min compared to those with CrCl greater than 50 mL/min. Consider these data when selecting antibacterial therapy for use in patients with baseline moderate/severe renal impairment.
Geriatric Use
Telavancin is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function.
