The U.S. Food and Drug Administration (FDA) recently authorized Incruse Ellipta for the treatment of airflow obstruction in patients who suffer from chronic obstructive pulmonary disease (COPD), as well as chronic bronchitis and emphysema. The umeclidinium drug, developed by GlaxoSmithKline plc (GSK), is an anticholinergic and is indicated for long-term, once-daily, continuance treatment.
Umeclidinium, the first once-daily anticholinergic from GSK, is a type of bronchodilator and works as a long-acting muscarinic antagonist (LAMA). It is also administered as a treatment using the Ellipta inhaler with an FDA-approved dose of 62.5 mcg. Ellipta is also an anticholinergic, which was already approved in the U.S. for longer-term once-daily continuance treatment of COPD.
“We believe Incruse Ellipta, our first mono therapy in the anticholinergic class, will be an important once-daily treatment option for appropriate patients with COPD,” said Darrell Baker, SVP & Head, GSK Global Respiratory Franchise. “GSK has a long-standing commitment to the development of respiratory medicines in order to offer physicians a choice of treatment options for their patients. We are delighted by this approval, and are looking forward to making Incruse Ellipta available for appropriate patients with COPD in the U.S.”
The launch of further R&D activities is expected to ramp up during the fourth quarter of 2014, given the announcement of the new approval. Seven clinical trials are currently underway, already in advanced phase III trials, and include over 2,500 patients with chronic obstructive pulmonary disease that are being treated either with umeclidinium or placebo.
Chronic obstructive pulmonary disease is an illness that affects the lungs, which may cause chronic bronchitis, emphysema or both, and causes airflow obstruction, which is why patients normally have problems breathing.
One of the main causes of COPD is long-term exposure to lung irritants, which damage the lungs and the airways. The most typical reasons for contact with lung irritants in the U.S. is cigarette smoking, however, second hand smoke, air pollution, chemical fumes, and dust from the environment or workplace can also cause the disease as well.
About 27 million people in the U.S. alone suffer from COPD, according to the National Heart, Lung, and Blood Institute (NHLBI), and most patients experience first symptoms around age 40.