Seebri Breezhaler approved in Europe
pharmafile | October 4, 2012 | News story | Sales and Marketing |Â Â COPD, Novartis, Relvar, Seebri Breezhaler, TudorzaÂ
Novartis has been given approval in Europe for its Seebri Breezhaler to be used as maintenance treatment for chronic obstructive pulmonary disease (COPD).
In the late-stage GLOW trials, Seebri Breezhaler (glycopyrronium bromide) significantly improved lung function over the first four hours following morning dosing – a benefit sustained for 24 hours over a 52-week period – compared to placebo.
The approved 44 mcg delivered dose will be given as a once-daily inhaled maintenance bronchodilator treatment to relieve COPD symptoms.
The GLOW2 study showed that the LAMA provided 24-hour bronchodilation and is superior to placebo and similar to open-label tiotropium – the active ingredient in Boehringer Ingelheim and Pfizer’s Spiriva – in improving lung function.
The brand also reduced shortness of breath, exacerbations and use of rescue medication, while improving quality of life and exercise tolerance compared to placebo.
COPD is important to Novartis: the company’s LABA Onbrez Breezhaler (indacaterol maleate), which has a different action to Seebri but also uses the Breezhaler device, is approved in Europe as a COPD maintenance treatment too.
David Epstein, division head of Novartis pharmaceuticals, said the company is now the first to offer two once-daily monotherapy bronchodilators with different modes of action.
In data released last month one of Novartis’ experimental respiratory drugs, the dual-bronchodilator QVA149, proved superior in a late-stage trial to Spiriva in helping patients breathe more easily.
It is a highly competitive therapy area: existing drugs include Spiriva, AstraZeneca’s Symbicort and GlaxoSmithKline’s blockbuster Advair (Seretide in the UK), the biggest-selling drug in the market.
Forest Laboratories’ Tudorza Pressair (aclidinium bromide) has been recently approved, and GSK and US biopharma firm Theravance have also submitted their investigational COPD drug Breo (Relvar in Europe) to the FDA and European authorities.
Adam Hill
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