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.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Weekly
    • FDAnews
  • Device News
    • Trending
    • Commercial Operations
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Weekly
    • FDAnews
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
    • Webinar Recordings
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • FDAnews Editorial Board
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Skin Infection Drug Sivextro Approved by FDA

Skin Infection Drug Sivextro Approved by FDA

June 30, 2014

The FDA approved Cubist Pharmaceuticals’ antibiotic Sivextro, the second drug approved for acute bacterial skin and skin structure infections as part of the agency’s effort to encourage the development of new antibiotics as a bulwark against growing drug resistance.

On May 23, the agency also approved Durata Therapeutics’ Dalvance (dalbavancin) for the same indication.

Sivextro (tedizolid phosphate) was approved under the qualified infectious disease products (QIDP) designation, created in 2012 to spur development of drugs for increasingly resistant pathogens. QIDP status grants a priority review, fast-track approval and five extra years of post-approval exclusivity under the Hatch-Waxman Act.

Cubist, which acquired Sivextro in its purchase of Trius Therapeutics last July, said it plans to invest $400 million and devote 75 percent of its employees in 2014 to R&D, commercialization and support of antimicrobial drugs. The firm hopes to produce at least four antibiotics between now and 2020, said spokeswoman Kim McCrossen.

The company currently has a combination drug of ceftolozane and tazobactam awaiting FDA approval by Dec. 21 for complicated urinary tract infections and complicated intra-abdominal infections. Cubist also is waiting on European Medicines Agency marketing authorization for Sivextro.

Even with the new approvals, “the pipeline for antibiotics is relatively dry,” Pew Director of Drug Safety and Innovation Elizabeth Jungman said. Pew had identified roughly 45 new antibiotics in development as of February, but only about nine of those are statistically likely to make it to market, and this will not be sufficient to meet future needs, she said.  

To further speed antibiotics to market, Pew and other groups have proposed a new pathway called Limited Population Antibacterial Drug (LPAD), which would allow the FDA to approve new antibiotics based on clinical trials with limited populations in cases of life-threatening and unmet medical needs. Under this model, companies attempting to market a drug that treats Staphylococcus aureus, for example, would be able to submit Phase II clinical data from the MRSA-specific patient population rather than data from larger Phase III trials incorporating patients with multiple strains of the bacterium.

The LPAD pathway was included in the Antibiotic Development to Advance Patient Treatment Act of 2013, which is now before the House Energy and Commerce Committee. — 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.

Drugs Submissions and Approvals

    Upcoming Events

    • 11Oct

      GMP Quality Management vSummit 2023: Where Quality Meets Risk

    • 16Oct

      MAGI@home Clinical Research Conference 2023

    • 26Oct

      FDA in 2024: What to Expect in an Election Year

    • 02Nov

      How UDI and UDI Data Can — and Must — Be Used for More Than Just Device Identification

    • 08Nov

      18th Annual FDA Inspections vSummit

    Featured Products

    • FDA, FTC and DOJ Enforcement of Medical Device Regulations

      FDA, FTC and DOJ Enforcement of Medical Device Regulations

    • Using Real-World Evidence in Drug and Device Submissions

      Using Real-World Evidence in Drug and Device Submissions

    Featured Stories

    • Adcomm Votes Down ALS Stem Cell Therapy, Debates Clinical Data vs. Personal Data

    • Reports Allege Philips Withheld Evidence of Ventilator Malfunctions for 11 Years

    • Summary Judgment Sought by Boehringer Ingelheim in its IRA Lawsuit

    • FDA Proposes New Rule on Who has Oversight on Lab Tests

    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 or Share My Data
    Footer Logo

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

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing