GlaxoSmithKline (GSK) has received US Food and Drug Administration (FDA) approval for Incruse Ellipta (umeclidinium) as an anticholinergic indicated for the once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Umeclidinium is a once-daily long-acting muscarinic antagonist (LAMA), a type of bronchodilator also known as an anticholinergic.
The company said that Incruse contains 62.5mcg umeclidinium 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 effective once-daily treatment option for certain 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."
After FDA approval, launch activities of Incruse Ellipta in the US are expected to start during the fourth quarter of 2014.
FDA approval is based on a Phase III pivotal programme that included seven clinical trials, involving more than 2,500 COPD patients treated with umeclidinium or placebo.
In April 2014, Incruse Ellipta has been approved by Health Canada to treat airflow obstruction in COPD patients, including chronic bronchitis and emphysema.
The company also received marketing authorisation in the EU for Incruse (umeclidinium) as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult COPD patients.
Most common adverse reactions with Incruse Ellipta were nasopharyngitis, upper respiratory tract infection, a cough, and arthralgia.
