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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.

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