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Boehringer COPD drug 'could give patients more independence'

New data shows Stiolto improves patients’ lives

 BI HQ

Boehringer Ingelheim's recently approved combination product for chronic obstructive pulmonary disorder (COPD) can dramatically improve patients' quality of life, according to two new trials.

Spiolto - which combines the active ingredients in Boehringer's long-acting muscarinic antagonist Spiriva (tiotropium) and long-acting beta agonist Striverdi (olodaterol) - was recently approved for marketing in the EU and the US (as Stiolto).

The new phase IIIb OTEMTO studies shows that Spiolto provides consistent improvements in lung function, breathlessness and quality of life compared to Spiriva, while patients on the drug also had less need for rescue medications to tackle breakthrough symptoms of COPD.

As there is no cure for COPD, improving quality of life - which is generally measured using the St George's Respiratory Questionnaire (SGRQ) scale - is a major goal of treatment, according to Boehringer.

A reduction in SGRQ score of four points or more is deemed clinically meaningful, and in the OTEMTO trials Spiolto achieved a reduction in SGRQ total score of 4.67 compared to placebo.

That degree of improvement in quality of life "could make a noticeable difference to the daily activity of COPD patients and enable them to maintain a more independent life," commented  OTEMTO trial lead investigator Dave Singh of the University of Manchester in the UK.

Boehringer needs Spiolto to hit the ground running as its faces increasing competition in the COPD market, with a number of other LAMA/LABA combinations jostling for elbow room in the market, including Novartis' Ultibro (glycopyrronium/indacaterol) and GSK's Anoro (umeclidinium bromide/vilanterol).

Moreover, with plentiful generic drugs available the respiratory sector is facing significant downward pricing pressure in the US - which has also affected GSK. With GSK forced to discount Advair and other drugs in its respiratory portfolio Spiriva has also come under pressure, with sales dropping around 8% last year according to EP Vantage data.

The company wants to transition patients to Spiolto from Spiriva - its biggest-selling drug with sales of €3.2bn last year. Spiriva and GlaxoSmithKline's beta agonist/inhaled corticosteroid (ICS) product Advair/Seretide (salmeterol and fluticasone propionate) accounted for around three quarter of the COPD market in 2013. Spiriva is due to lose patent protection in the key US market in 2018.

Article by
Phil Taylor

17th August 2015

From: Research

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