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

OINDPnews


Proveris Scientific
  • Home
  • News
    • Business
    • Features
    • Medical
    • Regulatory
    • Products and Services
    • People
  • Events
  • Suppliers
    • Supplier listing and advertising options
    • Capsules and blisters
    • Consultants
    • Contract research
    • Contract manufacturing
    • Devices
    • Education
    • Excipients
      • Clinical Technology
    • Filling equipment
    • Instruments
    • Particle manufacturing
    • Software and modeling
  • Jobs
  • Resources
    • Webinars
    • White papers
  • LGWP Propellants
    • HFA 152a
    • HFO-1234ze(E)
    • LGWP Regulation
  • Contact

Positive opinion from CHMP for umeclidinium monotherapy

Shortly after announcing that the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding Anoro umeclidinium/vilanterol, GSK has announced that CHMP also issued a positive opinion regarding umeclidinium monotherapy. According to GSK, the product would be marketed as “Incruse” and would deliver a 55 mcg dose of UMEC via the Ellipta dry powder inhaler.

GSK President of Pharmaceuticals R&D Patrick Vallance commented, “GSK is committed to the development of a range of respiratory medicines that allow physicians to make treatment choices based on their individual patients’ needs. The CHMP’s decision brings us a step closer to offering physicians a further once-daily treatment choice for appropriate COPD patients. We look forward to a final decision from the European Commission in the next few months.”

GSK submitted the marketing authorization application for UMEC monotherapy in April 2013 and announced the submission of an NDA for the product a few days later.

Read the GSK press release.

Share

published on February 21, 2014

Primary Sidebar

Sign up for our free weekly newsletter

Upcoming Events
Sponsored by Intertek

Want information about upcoming OINDP-related events delivered directly to your inbox? click here

  • June 17-June 18: Rescon Europe 2025, Paris, France
  • June 19-June 20: Metered Dose Inhaler (MDI) Technology Training Course, online
  • June 22-June 25: ISAM Congress 2025, Washington, DC, USA
  • June 25-June 25: SMI.London 2025, London, UK
  • September 18-September 19: IPAC-RS Nasal Innovation Forum, West Trenton, NJ, USA
  • See all upcoming events

    Secondary Sidebar

    Suppliers

    Capsules and blisters
    Consultants
    Contract research
    Contract manufacturing
    Devices
    Education
    Excipients
    Filling equipment
    Instruments
    Particle manufacturing
    Software and modeling
    Merxin We Make Inhalers banner
    © 2025 OINDPnews