Breo Ellipta for long-term treatment of COPD gets FDA nod

May 14, 2013

Fluticasone furoate and vilanterol inhalation powder combo is a long-term, once-daily maintenance treatment for COPD

FDA has approved fluticasone furoate and vilanterol inhalation powder (Breo Ellipta, GlaxoSmithKline and Theravance), an inhaled long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.

“FDA’s approval of Breo Ellipta offers another alternative and effective therapeutic option for many individuals who suffer from this chronic respiratory disease,” said Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, Webster, Texas. “The primary intent of this agent, similar to other agents, is to assist with disease state management and also ultimately help to improve quality of life over time.”

COPD refers to two lung diseases, chronic bronchitis and emphysema, that are characterized by obstruction to airflow that interferes with normal breathing. The National Heart, Lung and Blood Institute (NHLBI) estimates that as many as 27 million people in the United States alone are affected by COPD, a number that is predicted to increase.

According to the NHLBI, long-term exposure to lung irritants that damage the lungs and the airways is usually the cause of COPD. In the United States, cigarette smoke is the most common irritant that causes COPD. 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 of age when symptoms begin.

COPD-related exacerbations are typically defined as a worsening of symptoms that require medical intervention. 

"The FDA approval of Breo Ellipta brings an important inhaled, once-daily maintenance therapeutic option to COPD patients and doctors across the United States," Rick E. Winningham, chief executive officer of Theravance, said in a company press release.

It is anticipated that Breo Ellipta will be available in the United States during the third quarter of 2013. 

The materials submitted to FDA to support the regulatory review of fluticasone furoate and vilanterol inhalation powder included data from a comprehensive program of nonclinical studies, 52 clinical pharmacology studies of 1,406 patients, and 11 clinical studies of 7,851 patients with COPD. There were four primary COPD studies: two six-month lung-function studies and two one-year replicate exacerbation studies.