FDA Approves New Long-Term COPD Drug

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

The once-daily anticholinergic, umeclidinium, is a type of bronchodilator that works as a long-acting muscarinic antagonist (LAMA). It is approved at 62.5 µg strength, to be delivered via inhaler.
_____________________________________________________________________________________________________________________________________________________________________

RELATED CONTENT
Are Benzodiazepines Safe for Those with COPD?
Low Dose Opioids Tested in Patients with COPD
_____________________________________________________________________________________________________________________________________________________________________

The drug is contraindicated for patients with severe hypersensitive to milk proteins and should be used with caution for patients with narrow-angle glaucoma and urinary retention, especially prostatic hyperplasia or bladder neck obstruction.

The phase III program testing included 7 clinical studies for 2500 COPD patients, who were treated with either umeclidinium or placebo.

The most common adverse reactions included nasopharyngitis, upper respiratory tract infection, cough, and arthralgia. 

Incruse Ellipta will be distributed in the United States in the fourth quarter of 2014.

–Pooja Shah

References:

GSK receives approval for Incruise Ellipita (umeclidinium) in the US for the treatment of COPD [press release]. 2014 Apr 30. www.gsk.com/media/press-releases/2014/gsk-receives-approval-for-incruse-ellipta---umeclidinium--in-the.html. Accessed May 5, 2014.