Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's (GSK) Incruse Ellipta (umeclidinium) for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Subscribe to our email newsletter
Umeclidinium is a once-daily long-acting muscarinic antagonist (LAMA), a type of bronchodilator also known as an anticholinergic.
According to the company, Incruse contains 62.5mcg umeclidinium and is delivered by the Ellipta inhaler.
GSK senior vice president and head of Global Respiratory Franchise Darrell Baker said the company believes Incruse Ellipta, its first monotherapy in the anticholinergic class, will be an important once-daily treatment option for appropriate patients with COPD.
"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," Baker said.
"We are delighted by this approval, and are looking forward to making Incruse Ellipta available for appropriate patients with COPD in the US."
The launch activities of Incruse Ellipta in the US are expected to be initiated during the fourth quarter of 2014.
The FDA approval is based on a Phase III pivotal program that included seven clinical trials involving over 2,500 COPD patients treated with umeclidinium or placebo.
In April 2014, Incruse Ellipta has been approved by Health Canada and the European Commission for treatment of COPD.