New Data Highlighting in vitro Potency Advantages for VIBATIV® (telavancin) Against Difficult-to-Treat MRSA and MSSA Pathogens Reported at ASM Microbe 2017
Highlights from the VIBATIV presentations at ASM Microbe include:
Activity Against S. aureus Clinical Isolates Causing Skin Infections or Pneumonia with Concomitant Bacteremia
Researchers collected and analyzed S. aureus clinical isolates causing skin and skin-structure infections (SSSI) or pneumonia with concomitant bacteremia in US hospitals from 2012-2016. Results from the study demonstrated that VIBATIV possessed potent in vitro activity against this broad range of S. aureus clinical isolates, including those classified as methicillin-resistant and methicillin-susceptible (MRSA and
Importantly, the findings demonstrated greater in vitro activity for VIBATIV as compared to other well-known antibiotics such as vancomycin, daptomycin, ceftaroline and linezolid. Against subsets of isolates classified as MRSA, the MICs for VIBATIV were 8-fold lower than daptomycin, 16-fold lower than ceftaroline and 16- to 32-fold lower than vancomycin and linezolid. For those isolates classified as MDR, defined as displaying a resistance to three or more drug classes, the MICs for VIBATIV were 8-fold lower than daptomycin, 16- to 32-fold lower than vancomycin and linezolid, and 32-fold lower than ceftaroline.
Activity Against Cystic Fibrosis-Associated S. aureus, Including Ceftaroline-Resistant MRSA
Researchers collected and analyzed MRSA and
MRSA has a significant clinical impact on individuals with CF, resulting in worse survival as compared to CF patients who have never had MRSA.1 As such, CF-associated MRSA represents an area of significant medical need.
1 Dasenbrook EC, Checkley W, Merlo CA, Konstan MW, Lechtzin N, Boyle MP. Association Between Respiratory Tract Methicillin-Resistant Staphylococcus aureus and Survival in Cystic Fibrosis. JAMA.2010;303(23):2386-2392. doi:10.1001/jama.2010.791.
"We continue to work aggressively to generate compelling data to differentiate VIBATIV from other available antibiotics in some of the healthcare industry's most troubling and difficult-to-treat infection types. To this end, these latest data add to the impressive collection of research that demonstrates that VIBATIV has greater in vitro potency against a variety of MRSA and MDR infections than many well-known antibiotic products," said
About VIBATIV® (telavancin)
VIBATIV® was discovered internally in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus (S. aureus) and other Gram-positive bacteria, including MRSA and
VIBATIV is also approved for marketing in
VIBATIV® Important Safety Information
Patients with pre-existing moderate/severe renal impairment (CrCl ≤50 mL/min) who were treated with VIBATIV® for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia had increased mortality observed versus vancomycin. Use of VIBATIV in patients with pre-existing moderate/severe renal impairment (CrCl ≤50 mL/min) should be considered only when the anticipated benefit to the patient outweighs the potential risk.
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.
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.
Intravenous unfractionated heparin sodium is contraindicated with VIBATIV administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after VIBATIV administration.
VIBATIV is contraindicated in patients with a known hypersensitivity to the drug.
Serious and potentially fatal hypersensitivity reactions, including anaphylactic reactions, may occur after first or subsequent doses. VIBATIV should be used with caution in patients with known hypersensitivity to vancomycin.
Telavancin is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group.
Infusion Related Reactions
VIBATIV is a lipoglycopeptide antibacterial agent and should be administered over a period of 60 minutes to reduce the risk of infusion-related reactions. Rapid intravenous infusions of the glycopeptide class of antimicrobial agents can cause "Red-man Syndrome" like reactions including: flushing of the upper body, urticaria, pruritus, or rash.
Caution is warranted when prescribing VIBATIV to patients taking drugs known to prolong the QT interval. In a study involving healthy volunteers, VIBATIV prolonged the QTc interval. Use of VIBATIV should be avoided in patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure, or severe left ventricular hypertrophy.
Most Common Adverse Reactions
The most common adverse reactions (greater than or equal to 10% of patients treated with VIBATIV) were diarrhea, taste disturbance, nausea, vomiting, and foamy urine.
Full Prescribing Information, including Boxed Warning and Medication Guide in the
Our pipeline of internally discovered product candidates includes potential best-in-class medicines to address the unmet needs of patients being treated for serious conditions primarily in the acute care setting. VIBATIV® (telavancin), our first commercial product, is a once-daily dual-mechanism antibiotic approved in the
In addition, we have an economic interest in future payments that may be made by
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