Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50

FDA Approves First New Drug to Treat Influenza in Nearly 20 Years

By Catherine Sbeglia | October 24, 2018

The FDA has approved Genentech’s Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours. This is the first new antiviral flu treatment in nearly two decades.

“With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option,” said FDA Commissioner Scott Gottlieb, M.D.

“When treatment is started within 48 hours of becoming sick with flu symptoms, antiviral drugs can lessen symptoms and shorten the time patients feel sick,” said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs.”

Xofluza’s safety and efficacy was demonstrated in two randomized, controlled clinical trials of 1,832 patients where participants were assigned to receive either Xofluza, a placebo, or another antiviral flu treatment within 48 hours of experiencing flu symptoms. In both trials, patients treated with Xofluza had a shorter time to alleviation of symptoms compared with patients who took the placebo. The most common adverse reactions in patients taking Xofluza included diarrhea and bronchitis.

Genentech says the single-dose treatment will be available in the coming weeks, and while it will cost $150, it may be available through commercial insurance for $30.

 (Source: The U.S. Food & Drug Administration; CNBC)


Filed Under: Infectious Disease

 

Related Articles Read More >

Pfizer-BioNTech vaccine
U.S. government plans to stop paying for COVID-19 vaccines 
Monkeypox
U.S. to boost supplies of Tpoxx to fight monkeypox outbreak
Pfizer-BioNTech
Next-gen Pfizer-BioNTech vaccine candidates fare well in Phase 2/3 study
covid-19 vaccine
Fall 2022 COVID-19 vaccine candidate tracker

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Medtech100 Index
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50