GSK Wins FDA Clearance for New COPD Inhaler Incruse Ellipta

The FDA has approved GlaxoSmithKline’s Incruse Ellipta (umeclidinium), a once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), the company said Wednesday.

The product is GSK’s first once-daily anticholinergic, a type of bronchodilator also known as a long-acting muscarinic antagonist, the drugmaker said. The FDA-approved strength is 62.5 mcg umeclidinium, which will be delivered by GSK’s Ellipta inhaler. The U.S. approval follows recent market clearance for the product in Canada and Europe.

Pharmaceutical spending in the asthma/COPD therapeutic class is expected to reach $31 billion to $36 billion by 2017 in developed markets, according to the IMS Institute for Healthcare Informatics. Asthma/COPD is the fifth largest therapeutic class. The National Heart, Lung and Blood Institute estimates that nearly 27 million people in the U.S. alone are affected by COPD, a disease of the lungs that includes chronic bronchitis and/or emphysema.

Darrell Baker, senior vice president and head of GSK’s Global Respiratory Franchise, said the company believes Incruse Ellipta “will be an important once-daily treatment option for appropriate patients with COPD.” GSK said it anticipates launching the product in the fourth quarter of 2014.

Meanwhile, GSK and Theravance on April 28 announced that their COPD treatment Anoro Ellipta (umeclidinium and vilanterol inhalation powder) was now available in U.S. pharmacies. The drugmakers describe Anoro Ellipta as the first once-daily product approved in the U.S. that combines two long-acting bronchodilators in a single inhaler for the maintenance treatment of COPD. — Neal Learner

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