FDA Approves Incruse Ellipta (Umeclidinium) for COPD
Launch expected in fourth quarter of 2014
The FDA has approved Incruse Ellipta (umeclidinium, GlaxoSmithKline) as an anticholinergic indicated 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.
Umeclidinium — a type of bronchodilator known as a long-acting muscarinic antagonist (LAMA) — is contained in the Ellipta inhaler. The FDA-approved dose is 62.5 mcg.
It is anticipated that launch activities in the U.S. will begin during the fourth quarter of 2014.
The phase III pivotal trial program for umeclidinium included seven clinical studies that involved more than 2,500 patients with COPD treated with umeclidinium or placebo.
The most common adverse reactions observed with Incruse Ellipta and placebo included nasopharyngitis (8% and 7%, respectively), upper respiratory tract infection (5% and 4%), cough (3% and 2%), and arthralgia (2% and 1%). Other adverse reactions included atrial fibrillation.
COPD includes chronic bronchitis, emphysema, or both, and 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 U.S. have 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 U.S., 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.
Source: GlaxoSmithKline; April 30, 2014.