Market Overview

Glaxo, Theravance Confirm Positive CHMP Opinion for Relvar Ellipta

Share:
Related GSK
Five Prime Therapeutics Announces Oral Presentation of Initial Data From Ongoing Phase 1b Trial of FP-1039/GSK3052230 in Squamous Non Small Cell Lung Cancer and Mesothelioma at World Conference on Lung Cancer
US Stock Futures Slide Ahead Of Deere, Foot Locker Earnings
Veeva Beats Q2 Earnings on Strong Revenues, Guides Up (Zacks)
Related THRX
Short-Sellers Betting Against These Biotechs
Morning Market Losers

GlaxoSmithKline plc (NYSE: GSK) (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for fluticasone furoate/vilanterol (FF/VI) under the proposed brand name RELVAR(TM) ELLIPTA(TM) for;

Asthma: the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate:

-- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta2-agonists

COPD: the symptomatic treatment of adults with Chronic Obstructive Pulmonary Disease (COPD) with a FEV1 < 70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy

Relvar is a combination of the inhaled corticosteroid (ICS) fluticasone furoate "FF" and the long-acting beta2-agonist (LABA) vilanterol "VI". Two strengths of FF/VI are proposed for asthma (92/22 mcg and 184/22 mcg) and one strength is proposed for COPD (92/22 mcg). All strengths will be administered once-daily using the Ellipta, a new dry powder inhaler (DPI).

Posted-In: News FDA

 

Related Articles (THRX + GSK)

Get Benzinga's Newsletters