Boehringer Ingelheim: olodaterol set for US approval.
By Jacoba Procter, Content Manager
8 February 2013
I joined Datamonitor Healthcare as an analyst at the end of 2009 and I worked for a number of years covering immunology ...
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The FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 15-1 in favor of approval of olodaterol 5mcg as a once-daily maintenance bronchodilator for chronic obstructive pulmonary disease (COPD).
Boehringer Ingelheim is further asking that the FDA approve the drug with a label indicating that it increases patients’ exercise tolerance. If granted, it would be the first COPD therapy in the US to have this label. However, some panel members were against such a claim and there was no vote specifically related to it.
If approved, the company plans to launch the drug in the US with the brand name Striverdi Respimat, and it will be positioned as a combination partner for Boehringer Ingelheim’s COPD therapy Spiriva (tiotropium). Spiriva, a once-daily long-acting anticholinergic (LAMA), launched in the US in 2004 and enjoyed minimal competition, quickly becoming a blockbuster therapy used across all COPD disease severities. Until 2011 Spiriva remained the only once-daily bronchodilator in the US, but in that year Novartis launched Arcapta Neohaler (indacaterol), a once-daily long-acting beta 2 agonist (LABA). While Arcapta Neohaler posed little direct threat to Spiriva, and indeed can be used in combination with it, its availability does significantly change the market for olodaterol, reducing the need for this new monotherapy.
In the face of increasing competition and innovation in COPD, Boehringer Ingelheim is also developing olodaterol as part of a fixed-dose combination with Spiriva. That combination is in numerous ongoing Phase III trials looking at both lung function and exercise endurance. However, while LABA/LAMA combinations are highly anticipated and Datamonitor’s primary research suggests they would be welcomed with rapid uptake, Boehringer Ingelheim’s combination lags behind others in development.
Novartis, under license from Vectura and Sosei, is developing QVA149 (indacaterol/glycopyrronium bromide), which it filed in the EU in October 2012 and in Japan in November 2012. Boehringer Ingelheim could benefit from development of QVA149 in the US being delayed, but it will still face stiff competition from GlaxoSmithKline/Theravance, which filed their combination, Anoro (GSK573719/vilanterol), in the US in December 2012 and in the EU in January 2013. With a large patient pool eagerly awaiting simplified therapy options, the race is heating up.