Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Drugs
Published in: Drugs 15/2014

01-10-2014 | R&D Insight Report

Oritavancin: First Global Approval

Author: Anthony Markham

Published in: Drugs | Issue 15/2014

Login to get access

Abstract

Oritavancin (Orbactiv®) is a lipoglycopeptide antibacterial drug with activity against Gram-positive bacteria developed by The Medicines Company as a single-dose treatment for acute bacterial skin and skin structure infections (ABSSSI). The drug received its first global approval for this indication in the US in August 2014, and is under regulatory review in the EU. This article summarises the milestones in the development of oritavancin leading to this first approval for the treatment of ABSSSIs caused by Gram-positive bacteria.
Literature
1.
Zhanel GG, Calic D, Schweizer F, et al. New lipoglycopeptides: a comparative review of dalbavancin, oritavancin and telavancin. Drugs. 2010;70(7):859–86.PubMedCrossRef
2.
The Medicines Company. FDA approves The Medicines Company’s ORBACTIV(Tm) (oritavancin) for use in acute bacterial skin and skin structure infections [media release]. 2014.
3.
4.
5.
6.
The Medicines Company. European medicines agency accepts marketing authorization application for The Medicines Company’s oritavancin [media release]. 27 Feb 2014. http://​www.​themedco.​com.
7.
8.
9.
10.
11.
12.
Mendes RE, Farrell DJ, Sader HS, et al. Oritavancin microbiologic features and activity results from the surveillance program in the United States. Clin Infect Dis. 2012;54(SUPPL. 3):S203–13.PubMedCrossRef
13.
Farrell DJ, Mendes RE, Streit JM, et al. Current analysis of oritavancin potency when tested against vancomycin-resistant/susceptible enterococcal clinical isolates recovered from European medical centres (2009–2013) [abstract no. eP171]. In: 24th European Congress of Clinical Microbiology and Infectious Diseases; 10–13 May 2014; Barcelona, Spain.
14.
Farrell DJ, Mendes RE, Flamm RK, et al. Activity of oritavancin and comparator agents against multidrug-resistant staphylococcal and streptococcal isolates responsible for documented infections in European hospitals (2011–2013) [abstract no. aP172]. In: 24th European Congress of Clinical Microbiology and Infectious Diseases; 10–13 May 2014; Barcelona, Spain.
15.
Belley A, Arhin FF, Moeck G. Oritavancin does not antagonise the activity of common antibacterial agents for Gram-positive and Gram-negative infections [abstract no. eP174]. In: 24th European Congress of Clinical Microbiology and Infectious Diseases; 10–13 May 2014; Barcelona, Spain.
16.
McKay GA, Beaulieu S, Arhin FF, et al. Time-kill kinetics of oritavancin and comparator agents against Staphylococcus aureus, Enterococcus faecalis and Enterococcus faecium. J Antimicrob Chemother. 2009;63(6):1191–9.PubMedCrossRef
17.
Zhanel GG, Schweizer F, Karlowsky JA. Oritavancin: mechanism of action. Clin Infect Dis. 2012;54(suppl. 3):S214–9.PubMedCrossRef
18.
Darpo B, Lee SK, Moon TE, et al. Oritavancin, a new lipoglycopeptide antibiotic: results from a thorough QT study. J Clin Pharmacol. 2010;50(8):895–903.PubMedCrossRef
19.
Bellibas SE, Huang NY, Darpo B, et al. The effects of supratherapeutic dose of oritavancin on ECG intervals: a thorough QT study in health volunteers [abstract no. A-1307]. In: 54th Interscience Conference on Antimicrobial Agents and Chemotherapy; 5–9 September 2014; Washington, DC.
20.
Rubino CM, Van Wart SA, Bhavnani SM, et al. Oritavancin population pharmacokinetics in healthy subjects and patients with complicated skin and skin structure infections or bacteremia. Antimicrob Agents Chemother. 2009;53:4422–8.PubMedCrossRefPubMedCentral
21.
Rubino CM, Bhavnani SM, Moeck G, et al. Population pharmacokinetics (PPK) analysis for oritavancin (ORI) based on data from patients with acute bacterial skin and skin structure infectious (ABSSSI) [abstract no. A-1308]. In: 54th Interscience Conference on Antimicrobial Agents and Chemotherapy; 5–9 September 2014; Washington, DC.
22.
Fetterly GJ, Ong CM, Bhavnani SM, et al. Pharmacokinetics of oritavancin in plasma and skin blister fluid following administration of a 200-milligram dose for 3 days or a single 800-milligram dose. Antimicrob Agents Chemother. 2005;49(1):148–52.PubMedCrossRefPubMedCentral
23.
Moriarty SR, Rakhit A, Loutit J. Safety and pharmacokinetics of a single infusion of oritavancin in subjects with moderate hepatic insufficiency and in healthy controls [abstract no. A1-1289]. In: 49th Interscience Conference on Antimicrobial Agents and Chemotherapy; 12–15 September 2009; San Francisco, CA.
24.
Bhavnani SM, Hammel JP, Rubino CM, et al. Oritavancin pharmacokinetic-pharmacodynamic analyses for efficacy based on data from patients with acute bacterial skin and skin structure infections enrolled in SOLO I and SOLO II [abstract and poster no. A-1309]. In: 54th Interscience Conference on Antimicrobial Agents and Chemotherapy; 5–9 September 2014; Washington, DC.
25.
Corey GR, Kabler H, Mehra P, et al. Single-dose oritavancin in the treatment of acute bacterial skin infections. N Engl J Med. 2014;370(23):2180–90.PubMedCrossRef
26.
Corey R, Perez A, Moeck G, et al. A single-dose of oritavancin (ORI) is comparable to 7–10 days of vancomycin (VAN) in the treatment of acute bacterial skin and skin structure infections (ABSSSI): the SOLO II study [abstract no. L-206c]. In: 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy; 10–13 Sep 2013; Denver, Colorado.
27.
Holland TL, Corey GR, Wikler M, et al. A single dose of oritavancin (Ori) compared to 7–10 days of vancomycin (Van) in the treatment of acute bacterial skin and skin structure infections (Absssi): an analysis of the Mrsa subpopulation in the solo non-inferiority studies [abstract]. In: Hospital Medicine 2014; 24–27 March 2014; Las Vagas, Nevada.
28.
Corey GR, Wikler M, Jiang H, et al. A single dose of oritavancin (ORI) compared to 7–10 days of vancomycin (VAN): clinical response across different lesion types in the SOLO non-inferiority studies [abstract no. O152]. In: 24th European Congress of Clinical Microbiology and Infectious Diseases; 12–15 May 2014; Barcelona, Spain.
29.
Bates BM, Hartman CS, Wasilewski M. Oritavancin in the treatment of complicated skin and skin structure infections (cSSSI): combind results of two phase 3 multinational trials [abstract no. L-1514]. In: 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy/Infectious Diseases Society of America 46th Annual Meeting; 25–28 October 2008; Washington, DC.
30.
Dunbar LM, Milata J, McClure T, et al. Comparison of the efficacy and safety of oritavancin front-loaded dosing regimens to daily dosing: an analysis of the SIMPLIFI trial. Antimicrob Agents Chemother. 2011;55(7):3476–84.PubMedCrossRefPubMedCentral
Metadata
Title
Oritavancin: First Global Approval
Author
Anthony Markham
Publication date
01-10-2014
Publisher
Springer International Publishing
Published in
Drugs / Issue 15/2014
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-014-0295-4

Other articles of this Issue 15/2014

Drugs 15/2014 Go to the issue

R&D Insight Report

Suvorexant: First Global Approval

Therapy in Practice

Management of Non-Transfusion-Dependent Thalassemia: A Practical Guide

Adis Drug Evaluation

Dabigatran Etexilate: A Review of Its Use in the Treatment of Acute Venous Thromboembolism and Prevention of Venous Thromboembolism Recurrence

Erratum

Erratum to: Clinical Use of Rivaroxaban: Pharmacokinetic and Pharmacodynamic Rationale for Dosing Regimens in Different Indications

Adis Drug Evaluation

Albumin-Bound Paclitaxel: A Review of Its Use for the First-Line Combination Treatment of Metastatic Pancreatic Cancer

Erratum

Erratum to: Idelalisib: First Global Approval