We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA Approves Antibacterial Orbactiv Under New Incentive Pathway

FDA Approves Antibacterial Orbactiv Under New Incentive Pathway

August 13, 2014

The FDA has approved The Medicines Company’s intravenous skin disease treatment Orbactiv, the third such product cleared this year under a pathway that provides manufacturers incentives to develop new antibiotics for serious or life-threatening infections.

Orbactiv (oritavancin) is indicated for acute bacterial skin and skin structure infections (ABSSSI) caused by bacteria such as methicillin-resistant Staphylococcus aureus (MRSA), the agency said. The drug was designated a qualified infectious disease product (QIDP) under the 2012 Generating Antibiotic Incentives Now Act, which aims to accelerate new treatments for increasingly resistant infections.

In light of this growing challenge, a single, once-only IV therapy such as Orbactiv offers the option to administer a single treatment in the outpatient setting for patients with skin infections caused by Gram-positive bacteria likely due to MRSA, said Charles Pollack, chair of the department of emergency medicine at Pennsylvania Hospital.

In two clinical trials of 1,987 adults with ABSSSI, many of whom had confirmed cases of MRSA, Orbactiv was as effective as the comparator drug, vancomycin — an antibiotic whose injectable form is generally only given to patients with severe infections, according to the Mayo Clinic.

As part of its QIDP designation, Orbactiv received a priority review and five extra years of marketing exclusivity. Two other products have won approval recently under QIDP: Durata Therapeutics’ Dalvance (dalbavancin) in May and Cubist Pharmaceutical’s Sivextro in June.

The Medicines Company said that it has submitted a marketing authorization application to the European Medicines Agency, which is likely to issue a decision in the first half of next year. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.

Pharmaceuticals Submissions and Approvals

Upcoming Events

  • 27Jan

    Medical Device Clinical Trials in China: Latest Regulatory Developments

  • 27Jan

    FDA’s Response to COVID-19: Fundamentals of Obtaining Emergency Use Authorizations

  • 09Feb

    Maintaining Your Risk-Based Cleaning and Disinfectant Programs: Best Practices During COVID-19

  • 10Feb

    FDA Under the Biden Administration: What’s to Come and What It Will Mean

  • 11Feb

    Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

  • 17Feb

    Effective Auditing for Manufacturing Quality

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Regeneron logo

    Regeneron’s Antibody Cocktail Shows Efficacy as COVID-19 Treatment

  • Mobile apps client cellphone cell phone

    FDA to Review Berkshire’s 510(k) Submission for Remote Drug-Delivery System

  • COVID-19

    Desidustat Improves Oxygenation for Hospitalized COVID-19 Patients

  • abbott-logo.gif

    Abbott’s Panbio COVID-19 Test Gets Additional CE Marks

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing