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FDA Advisory Committee Endorses GlaxoSmithKline’s Drug as COPD Treatment

An advisory committee to the U.S. Food and Drug Administration approved this week a maintenance drug for people with chronic obstructive pulmonary disease (COPD).

According to GlaxoSmithKline (GSK), the Pulmonary-Allergy Drugs Advisory Committee backed the efficacy and safety of the proposed use of BREO™ ELLIPTA™ — a once-daily inhaled treatment for the long-term, maintenance treatment of airflow obstruction in patients with COPD.

“We are pleased with the outcome of today’s meeting.  COPD is a debilitating and progressive disease,” Patrick Vallance, GSK’s President of Pharmaceuticals, R&D, said in a news release.

The UK-headquartered pharmaceutical company collaborated with Theravance, Inc., a California-based biopharmaceutical company, in developing the program which took 10 years.

Vallance said the recommendation by the advisory committee is an important first step towards making BREO available for COPD patients across the United States. Before the year ends, the FDA is expected to make its final decision on whether the experimental drug will be made available to Americans with COPD.

COPD is the third leading cause of death in the United States, with approximately 126,005 deaths in 2005. Tobacco use is blamed as a key factor in the development and progression of COPD, but asthma, exposure to air pollutants in the home and workplace, genetic factors, and respiratory infections also play a role, according to the Centers for Disease Control and Prevention.

Tags: COPD, COPD disease, COPD treatment, GlaxoSmithKline COPD drug treatment
April 18, 2013 at 10:00 am
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