Please login to the form below

Not currently logged in

GSK submits COPD drug in US and EU

Umeclidinium bromide intended as monotherapy for lung condition

GlaxoSmithKline (GSK) has submitted umeclidinium bromide for regulatory approval in the US and EU as a monotherapy for patients with chronic obstructive pulmonary disease (COPD).

The drug is a long-acting muscarinic antagonist (LAMA) and is already under review in both regions as part of the combination therapy Anoro, where it is combined with the long-acting beta agonist (LABA) vilanterol.

However, GSK has large-scale plans in respiratory to cope with the loss of patent protection for dominant COPD and asthma treatment Advair, and this includes marketing both combinations of its investigational molecules and monotherapy versions to suit different needs for patients.

The latest submission for umeclidinium bromide, formerly known as GSK573719, concerns the medicine's use as a long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema.

It is designed to be administered using GSK's Ellipta inhaler, and filings in other regions are expected throughout 2013.

In addition to umeclidinium bromide and Anoro, GSK's planned products in respiratory include a combination of fluticasone furoate and vilanterol intended to be marketed as Relvar in Europe and Breo in the US.

The medicine took a step closer to US approval last month when an FDA panel voted in favour of the drug's use as a once-daily maintenance treatment for COPD.

GSK isn't the only company looking to make the most of an increasing respiratory market, and other companies to get in on the act include AstraZeneca, which has already gained approval for the use of Symbicort (budesonide/formoterol) in treating COPD.

Other COPD products coming through development include Boehringer Ingelheim's olodaterol, which has also received backing from an FDA panel, Novartis' QVA149 (glycopyrronium bromide and indacaterol maleate) and Forest Labs/Almirall's aclidinium bromide/formoterol candidate.

2nd May 2013

From: Research, Sales



Featured jobs

Subscribe to our email news alerts


Add my company
McCann Complete Medical

Complete Medical delivers world-class solutions in medical communications, regulatory services, market access, healthcare digital excellence, and strategic consultancy. We bring...

Latest intelligence

What is a patient-centric brand anyway?
It’s hard to believe that in our industry, there have been ongoing rumblings about patient-centricity for years now. Sure, there are some great companies who have worked hard to bring...
‘Less Is More: Making Patient-Centered Digital Communication a Reality’
Letizia Affinito writes on the Gower Publishing blog....
The Seven Cs Of Cross-Functional Brand Planning
As more and more organisations have moved to cross-functional and cross-regional involvement in the development of their strategic and operational brand plans, the result has been greater engagement and alignment,...