September 9, 2015
By Alex Keown, BioSpace.com Breaking News Staff
LONDON – GlaxoSmithKline ’s Breo Ellipta, an inhalant for the treatment of chronic obstructive pulmonary disease (COPD), did not significantly increase chances of survival for patients battling both the lung disorder and cardiovascular issues, the company announced Tuesday.
London-based GSK announced the ambitious study of 16,485 patients from 43 countries who were battling both COPD and a history of cardiovascular disease, failed to meet its survivability endpoints, despite the fact that 12 percent of patients taking the drug had a lower risk of dying. Still, GSK and its partner Theravance, Inc. said the number was not statistically significant. Additionally, the drug reduced the risk of experiencing an on-treatment cardiovascular event, including death, myocardial infarction, stroke, unstable angina and transient ischemic attack by 7.4 percent, but that was not considered statistically significant.
Theravance’s stock dropped 14 percent following the announcement. Stock was trading at $11.61 per share as of this writing. Eric Dube, GSK’s respiratory chief, said that although the trial did not show a statistically significant result, Breo will continue to play an important role in the treatment of people with COPD.
Reuters projected Breo Ellipta, which was licensed from Theravance Inc. in 2002, to generate $1.55 billion in annual sales by 2020.
Breo Ellipta consists of a corticosteroid, which reduces inflammation, and vilanterol, a long-acting beta-agonist (LABA), which is designed to open the airways. The medication was approved by the FDA in May 2013 for use as a once-daily prescription medication for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. In May the FDA approved Breo Ellipta for the treatment of asthma in adults.
If Breo had been shown to increase the life expectancy of those battling COPD and cardiovascular issues, analysts expected sales of the drug to increase exponentially, particularly as the company is facing increased competition in the asthma market.
GSK faced a similar situation nearly a decade ago when a smaller study of its blockbuster Advair narrowly missed its trial endpoints of helping increase life expectancy of those with chronic lung and cardiovascular issues, Reuters said.
Last month GlaxoSmithKline announced it will hire more than 100 people for the Zebulon, N.C. facility as it ramps up production of its next generation asthma drug Breo Ellipta. The Zebulon site recently added a new assembly line to support the manufacture of Breo Ellipta and its other Multi-Dose Dry Powder Inhalers.
Glaxo initially filed a new drug application to use Breo Ellipta as an asthma treatment in June 2014. The LABA class of drugs has been linked with asthma-related deaths in the past. Before the drug was approved for the treatment of asthma, the FDA panel recommended that a large LABA safety trial should be required in adults and in youths 12 to 17 years of age. The trials are similar to ongoing LABA safety trials being conducted as an FDA Post-Marketing Requirement by each of the manufacturers of LABA containing asthma treatments, including GlaxoSmithKline‘s Advair, AstraZeneca PLC ‘s Symbicort and Merck & Co. ‘s Dulera and Foradil, in both adolescents and adults, GlaxoSmithKline said following the panel’s ruling. LABA drugs already come with warning labels noting the risks of taking such a medication.
