GlaxoSmithKline presented positive results from two studies comparing its chronic obstructive pulmonary disease treatment Incruse Ellipta, or umeclidinium inhalation powder, with Boehringer Ingelheim's Spiriva, or tiotropium, and Novartis' Seebri, or glycopyrronium. The study evaluating the drug against tiotropium showed patients who received Incruse Ellipta had significantly better lung function improvement, while the study comparing it with glycopyrronium yielded similar outcomes between the two treatments.
Boehringer Ingelheim's Stiolto Respimat, an oral spray formulation of olodaterol and tiotropium, has been approved by the FDA as a long-term treatment for chronic obstructive pulmonary disease. The drug's label will include a boxed warning stating that long-acting beta-agonists can raise the risk of asthma-related mortality.
Boehringer Ingelheim obtained the FDA's approval to market its long-acting beta-agonist Striverdi Respimat, or olodaterol, as a maintenance therapy for chronic obstructive pulmonary disease. The drug's label will include a boxed warning that long-acting beta-agonists can raise asthma-related mortality risk.
An FDA panel voted 15-1 to endorse Boehringer Ingelheim's olodaterol as a treatment for chronic obstructive pulmonary disease. The panel believed that Boehringer provided substantial evidence of the safety and long-term efficacy of the drug, which would be sold as a soft mist inhaler under the name Striverdi Respimat.
The FDA approved Combivent Respimat Inhalation Spray, Boehringer Ingelheim's treatment for patients with
chronic obstructive pulmonary disease. The therapy comprises albuterol sulfate and ipratropium bromide.
It is a "suitable alternative" to chlorofluorocarbon-based Combivent Inhalation Aerosol, which
will be phased out after Dec. 31, 2013, according to an FDA statement.