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GSK and Theravance file COPD combo for EU approval

Filing for LAMA/LABA combination comes shortly after US submission

GlaxoSmithKline and Theravance have filed their new combination chronic obstructive pulmonary disease (COPD) drug Anoro in the EU, shortly after a similar application in the US.

The new product is a combination of the long-acting muscarinic antagonist (LAMA) umeclidinium bromide with vilanterol, a long-acting beta agonist (LABA), and is one of several LAMA/LABA combinations approaching the market for COPD.

The EU marketing application positions Anoro as a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD, a market which has been predicted to be worth several billions of dollars a year.

Last July, GSK and Theravance reported the results of four trials of umeclidinium/vilanterol, including two efficacy studies that compared the combination to its components given separately and placebo and two active comparator studies against Pfizer/Boehringer Ingelheim's LAMA Spiriva (tiotropium).

Regulatory submissions for the combination are also planned in other countries in 2013, and GSK has also said it intends to file umeclidinium as a monotherapy later this year.

Theravance and GSK also collaborated on the development of Relvar/Breo for COPD, a product which combines vilanterol with the once-daily inhaled corticosteroid fluticasone furoate.

Marketing applications for this product were filed in both the US (COPD) and EU (COPD and asthma) last July as a follow-up to GSK's big-selling Seretide/Advair (fluticasone propionate and salmeterol) product, sales of which are around $8bn in asthma and COPD but have slowed with the start of generic competition in some markets.

If approved, Anoro will enter a market that is currently dominated by Spiriva and Advair, while several new drugs are also set to becoming available. Forest Labs launched a new LAMA product Tudorza (aclidinium bromide) in the US last month and is also developing a LAMA/LABA combination with Almirall - adding in formoterol - which is in phase III.

Other LAMA/LABA combinations coming through development include Boehringer's olodaterol/tiotropium and Novartis' QVA149 (glycopyrronium bromide and indacaterol maleate) which are both expected to reach the market later this year.

11th January 2013

From: Sales

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