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, Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Daily Bulletin
    • Drug Industry Daily
  • Device News
    • Trending
    • Commercial Operations
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Daily Bulletin
    • FDAnews Device Daily Bulletin Premium
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • eCFR and Guidances
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA Approves BioCryst’s Rapivab Influenza Drug

FDA Approves BioCryst’s Rapivab Influenza Drug

January 6, 2015

BioCryst said it would start shipping its influenza drug Rapivab following FDA approval of the first new antiviral flu therapy in 15 years.

Rapivab (peramivir) is indicated as a single injection to treat adults who have shown symptoms of uncomplicated influenza for no more than two days. Two other drugs exist in its class, one that is inhaled and the other that is oral.

Many influenza patients experience both vomiting and respiratory symptoms, which might make it difficult to either swallow or inhale a drug, Jon Stonehouse, BioCryst’s president and CEO, said.

Another concern with existing therapies is that many patients don’t take their medications properly once they return home, he said. With Rapivab, doctors can easily administer the single intravenous dose at the hospital, Stonehouse added.

The drug won approval based on 27 clinical trials of roughly 2,700 patients in which subjects treated with one dose of the drug had symptoms disappear 21 hours sooner than did patients on placebo. BioCryst originally tested Rapivab both for uncomplicated influenza and for hospitalized influenza patients, but was forced to pull the second indication after disappointing Phase III data.

BioCryst received support for the drug from the Biomedical Advanced Research and Development Authority, a federal program dedicated to developing treatments for use in public health emergencies. — Lena Freund

Drugs Submissions and Approvals

Upcoming Events

  • 04Apr

    Optimizing Quality Control Operations with Unified Quality

  • 20Apr

    Medical Device Enforcement: Latest Developments from the FDA, DOJ and FTC

  • 25Apr

    Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

  • 27Apr

    Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

  • 17May

    2023 WCG Avoca Quality Consortium Summit

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • Prolira’s Beside EEG Monitor Cleared for Acute Brain Failure

  • Britain’s Pharma Association Suspends Novo Nordisk’s Membership

  • Cotras Gets FDA Approval of Virtual Reality Rehab Device

  • FDA Approves Novartis Treatment Combination for Pediatric Glioma

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