European Commission Approves GSK's Incruse For COPD

GlaxoSmithKline announced that it has secured marketing authorization from the European Commission for Incruse (umeclidinium) as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Incruse is a 55mcg strength inhalation powder administered via the Ellipta inhaler. The drug is a once-daily long-acting muscarinic antagonist (LAMA), a type of bronchodilator also known as an anticholinergic.

Darrell Baker, SVP & Head of GSK Global Respiratory Franchise, said, “COPD affects millions of people in Europe and for many years we have been committed to researching and improving understanding of it. We are delighted by today’s marketing authorization for Incruse Ellipta, our first LAMA, which will provide healthcare professionals with a further treatment option for appropriate COPD patients. This is in line with our goal to develop a range of respiratory medicines that allow physicians to make treatment choices based on their individual patients’ needs.”

Chronic obstructive pulmonary disease (COPD) is an umbrella term that includes diseases such as chronic bronchitis, emphysema, or both. The disease is characterized by obstruction to airflow that interferes with normal breathing. Long term exposure to lung irritants such as cigarette smoke, second hand smoke, air pollution, chemical fumes, or dust can all contribute to the disease. Most patients that have COPD are at least 40 years old when they first experience symptoms. COPD affects an estimated 4 to 10 percent of the adult population in Europe.

The EMA assessment of the drug included a review of seven Phase III clinical trials, including more than 2,500 COPD patients. Umeclidinium was granted license in Canada under the brand name Incruse Ellipta. A New Drug Application (NDA) for Incruse is under review by the FDA.

The company said it expects the first launches of the drug in Europe by the end of 2014.