FDA approves Incruse Ellipta for COPD

FDA approved umeclidinium (Incruse Ellipta, GlaxoSmithKline) once-daily anticholinergic for long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. 

Umeclidinium is GSK’s first once-daily anticholinergic, a type of bronchodilator also known as a long-acting muscarinic antagonist (LAMA). It is approved with the Ellipta inhaler. Its approved strength is 62.5 µg.

The drug’s anticipated launch in the United States will be during the fourth quarter of 2014.

The phase 3 randomized, placebo-controlled clinical studies for umeclidinium included seven clinical studies, which involved more than 2,500 COPD patients treated with umeclidinium or placebo. Nasopharyngitis (8%), upper respiratory tract infection (5%), cough (3%), and arthralgia (2%) were the most common adverse events.

GSK’s other approved drugs for COPD are Breo Ellipta, a fluticasone furoate and vilanterol inhalation powder and Anoro Ellipta, umeclidinium and vilanterol inhalation powder.

The National Heart, Lung and Blood Institute (NHLBI) estimates that nearly 27 million people in the United States alone have COPD. Most individuals first exhibit symptoms associated with COPD at approximately mid-life or 40 years old.