• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

FDA to review Theravance’s application for once-daily COPD med

January 29, 2018 By Sarah Faulkner

Mylan, Theravance BioPharmaThe FDA has accepted Theravance Biopharma‘s (NSDQ:TBPH)  marketing application for revefenacin, an inhaled long-acting muscarinic antagonist designed to treat chronic obstructive pulmonary disease.

The FDA is slated to make a decision about the once-daily treatment by Nov. 13.

“The acceptance of our NDA moves us closer to providing COPD patients with access to once-daily, nebulized LAMA therapy. With positive results in our Phase 3 program, we believe that revefenacin is well positioned to fill this important need,” Theravance chairman & CEO Rick Winningham said in prepared remarks. “I commend the team at Theravance Biopharma and Mylan for producing a high quality submission, and we look forward to working with the FDA in its review of our application.”

Theravance has partnered with Mylan (NSDQ:MYL) to develop and commercialize its nebulized revenfenacin products. According to the terms of the deal, Theravance holds rights to revenfenacin in the U.S., while Mylan has rights outside the U.S. The deal could bring Theravanace as much as $220 million in milestones from Mylan, as well as double-digit royalties on sales outside the U.S. The two companies are slated to share profits made on sales within the States.

“Today, patients with moderate to severe COPD do not have access to a nebulized LAMA as a treatment option yet. We believe revefenacin, when approved, represents an important advancement in respiratory care by offering a convenient once-daily option for patients, and further strengthens Mylan’s robust and growing respiratory portfolio,” Mylan President Rajiv Malik added. “We are extremely pleased that the revefenacin NDA has been accepted for FDA review, as it demonstrates the success of our collaboration with Theravance Biopharma, our collective expertise in complex products and the quality of the revefenacin development program.”

In two replicate pivotal Phase III trials, revefenacin showed statistically significant and clinically meaningful improvements after 12 months compared to a placebo. The drug also had comparable rates of adverse events when compared with a placebo.

If approved, the product would compete with Sunovion‘s Sun-101/eFlow drug-device combo – the first nebulized long-acting muscarinic antagonist approved for the treatment of COPD in the U.S. The system includes a portable nebulizer that delivers the drug in two to three minutes and allows the user to breathe normally while the drug is administered.

Sunovion expects its product to be available in pharmacies early this year.

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Respiratory, Wall Street Beat Tagged With: Mylan, Theravance Biopharma

IN CASE YOU MISSED IT

  • Medtronic enrolls first patient in study for Onyx liquid embolic system
  • BD issues voluntary recall on certain Alaris infusion pump modules
  • Sequel Med Tech expects full twiist launch in the fall
  • Insulet hires new chief HR officer from J&J
  • Breakthrough T1D, Mattel debut Barbie doll with type 1 diabetes

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. 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 | RSS