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

Drug Delivery Business

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

Mylan, Theravance touts Phase III data for COPD drug

October 20, 2016 By Sarah Faulkner

Mylan, TheravanceMylan (NSDQ:MYL) and Theravance Biopharma, Inc. (NSDQ:TBPH) said today that revefenacin, the 1st nebulized bronchodilator in development for the treatment of chronic obstructive pulmonary disease, demonstrated positive results in 2 replicate phase III efficacy studies.

Data from more than 1,250 moderate to severe COPD patients showed that both studies met their efficacy and safety endpoints. Revefenacin demonstrated statistically significant improvements to COPD symptoms over the course of 12 weeks compared to a placebo.

The 2 dosage levels of revenfenacin were well-tolerated, with comparable rates of adverse and serious events across both treatment groups, the companies reported. The most common adverse event were exacerbations, cough, dyspnea, and headache.

“We are extremely pleased with the outcome of these pivotal Phase 3 efficacy studies. The impressive improvements in [forced expiratory volume in one second] have exceeded our expectations, particularly when one considers that in nearly 40% of the patients we added revefenacin to their existing LABA or LABA/ICS therapy. These data confirm that revefenacin has the potential to offer meaningful benefits to patients with moderate to very severe COPD,” Theravance chief medical officer Dr. Brett Haumann said in prepared remarks. “As the first once-daily nebulized bronchodilator of any class in late-stage development, combined with its compatibility with any standard jet nebulizer, revefenacin is uniquely positioned to address a key unmet need in the treatment of COPD. We look forward to completing our ongoing Phase 3 safety trial in 2017, with the goal of filing an NDA by the end of 2017.”

“The positive results from these Phase 3 studies represent another exciting milestone in Mylan’s robust global respiratory pipeline,” Mylan prez Rajiv Malik added. “We are very pleased with our collaboration with Theravance Biopharma and their work advancing this important program, and we look forward to continuing to work together to bring this product to market. We believe Mylan’s strong experience with nebulized products and experienced salesforce in the respiratory segment, which has been further enhanced through our Meda transaction, will help ensure this product’s success if approved.”

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Respiratory Tagged With: Mylan, Theravance Biopharma

IN CASE YOU MISSED IT

  • Embecta stock soars on first full-quarter results after BD spinoff
  • Abbott will spend $450M to up FreeStyle Libre production in Ireland
  • Better Therapeutics Q2 beats Street as it prepares to submit diabetes therapy for FDA review
  • Study backs Fluidx embolic device for vessel filling
  • Senseonics stock is up as it sticks by revenue guidance

Primary Sidebar

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.
Need Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Signup for the newsletter

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
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2022 · 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.

Advertise | Privacy Policy | RSS