• 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

Theravance Biopharma touts expanded FDA nod for GSK’s Trelegy Ellipta inhaler

April 25, 2018 By Fink Densford

Theravance Biopharma

Theravance Biopharma‘s (NSDQ:TBPH) said today that the FDA granted expanded indications for GlaxoSmithKline‘s (NYSE:GSK) Trelegy Ellipta inhaler, now approved for use to treat a broader population of chronic obstructive pulmonary disease patients.

With the expansion, the inhaler is now cleared for COPD patients with airflow limitations and for those who have experienced an acute worsening of respiratory symptoms, the Dublin-based company said. The system is intended as a long-term, once-daily maintenance to treat airflow obstructions, as well as to reduce exacerbations of COPD.

Theravance said it has an interest in the Trelegy Ellipta because it is entitled to receive an 85% economic interest in roylaties paid by GSK on worldwide net sales, which it said are upward-tiering from 6.5% to 10%. Theravance said it expects resulting cash flows of approsimatly 5.5% to 8.5% for worldwide sales of the inhaler, according to a press release.

In January, Theravance Biopharma announced that the FDA accepted its marketing application for revefenacin, an inhaled long-acting muscarinic antagonist designed to treat chronic obstructive pulmonary disease.

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Respiratory Tagged With: Theravance Biopharma

IN CASE YOU MISSED IT

  • Senseonics stock is up on Q2 results
  • MedAlliance wins second FDA IDE nod for drug-coated balloon
  • Wells Fargo downgrades Tandem amid rise of automated insulin delivery competition
  • FDA approves first targeted infusion therapy for HER2-low breast cancer
  • Abbott, WeightWatchers partner on diabetes care

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