Supplier News Breaks Archives
GSK, Theravance inhaler for COPD cleared by FDA
December 18th, 2013
LONDON and SOUTH SAN FRANCISCO – GlaxoSmithKline plc and Theravance Inc. have received Food and Drug Administration approval for Anoro Ellipta as a combination anticholinergic/long-acting beta2-adrenergic agonist (LABA) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
The companies said Wednesday that Anoro Ellipta (umeclidinium and vilanterol inhalation powder) is the first once-daily product approved in the United States that combines two long-acting bronchodilators in a single inhaler for the maintenance treatment of COPD. The FDA-approved strength is umeclidinium/vilanterol 62.5 mcg/25 mcg.
"We believe Anoro Ellipta will be an important treatment option for appropriate patients with COPD," stated Darrell Baker, senior vice president and head of the GSK Global Respiratory Franchise. "It is the first combination product approved in the U.S. that delivers two once-daily bronchodilators in a single inhaler. This approval is a significant achievement for GSK."
With the drug's approval by the FDA, the companies said they expect to begin its U.S. launch during the first quarter of 2014.
"We are very pleased that Anoro Ellipta has become the first once-daily dual bronchodilator approved in the U.S. for the treatment of COPD," commented Rick Winningham, chief executive officer of Theravance. "This is a significant milestone for Theravance and GSK and is testament to our ongoing partnership and shared commitment to the development of respiratory medicines."
COPD is a disease of the lungs that includes chronic bronchitis, emphysema or both. COPD is characterized by obstruction to airflow that interferes with normal breathing. The National Heart, Lung and Blood Institute (NHLBI) estimates that nearly 27 million people in the United States are affected by COPD.
According to the NHLBI, long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD. In the United States, the most common irritant that causes COPD is cigarette smoke. Breathing in second-hand smoke, air pollution, chemical fumes or dust from the environment or workplace also can contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin.