FDA Approves GSK’s Respiratory Drug Incruse ElliptaBy
GlaxoSmithKline plc (GSK) has received FDA approval for Incruseâ„¢ ElliptaÂ® (umeclidinium) as an anticholinergic indicated for the long-term, once-daily, 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 and is contained in the ElliptaÂ® inhaler. The FDA-approved strength is 62.5 mcg.
Following this approval by the FDA, it is anticipated that launch activities in the US will begin during the fourth quarter of 2014.
In December 2013, GSK received approval for Anoro Ellipta (umeclidinium and vilanterol inhalation powder), a combination of the anticholinergic umeclidinium, and vilanterol, a long-acting beta2 adrenergic agonist (LABA), indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD.