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Novartis' QVA149 for COPD meets targets in phase III trials

Results put it on course for European regulatory filings around the end of this year

Novartis' combination respiratory drug QVA149 has met its targets in three phase III trials in patients with chronic obstructive pulmonary disease, placing it on course for regulatory filings in the EU and Japan around the end of this year.

The product could be the first COPD drug to combine a long-acting beta agonist (LABA) with a long-acting muscarinic antagonist (LAMA) in a once-daily formulation, a profile which has led to predictions of annual peak sales between $3bn and $5bn.

QVA149 combines indacaterol with glycopyrronium bromide, a LAMA licensed from Vectura of the UK and Japanese partner Sosei Corp which is currently under regulatory review in Europe and Japan.

The three phase III trials - SHINE, BRIGHT and ENLIGHTEN - are the first in a series of 10 studies collectively known as the IGNITE programme designed to support regulatory submissions for QVA149.

SHINE showed that once-daily QVA149 improved lung function more effectively than indacaterol or glycopyrronium bromide given alone in more than 2,100 patients with moderate-to-severe COPD.

Meanwhile, the BRIGHT study showed that patients had a significantly better exercise endurance versus placebo, according to Novartis, while ENLIGHTEN found that QVA149 was well tolerated and had a safety and tolerability profile similar to placebo.

Seven of the IGNITE trials are due to complete this year - including a head-to-head trial with GlaxoSmithKline's rival COPD treatment Seretide/Advair (salmeterol and fluticasone propionate) - and will be used to support the EU and Japanese filings.  Seretide is given twice-daily and is the top-selling COPD drug worldwide, with sales of £5.06bn ($8.1bn) last year.

QVA149's development in the US is still in question because of a decision by the US Food and Drug Administration (FDA) last year to request additional clinical data on QVA149 and glycopyrronium bromide (NVA237) delivered as a monotherapy.

However, another Novartis indacaterol-based product, its once-daily Arcapta Neohaler, was launched in the US last month and the company's Seebri Breezhaler (glycopyrronium bromide) COPD treatment is currently being considered by European regulators.

3rd April 2012

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