GSK's Anoro Ellipta shows efficacy in COPD, say FDA briefing papers

UK drug major GlaxoSmithKline’s (LSE: GSK) Anoro Ellipta (vilanterol/umeclidinium) to treat chronic obstructive pulmonary disorder (COPD) has shown strong efficacy, the US Food and Drug Administration noted in briefing documents ahead of an advisory committee meeting tomorrow.

The drug is a once-daily fixed-dose LAMA/LABA combination product aimed to optimize bronchodilator response. It has the potential to offer improved convenience and compliance over the use of single long-acting bronchodilators from separate inhalers.

Umeclidinium (UMEC), the LAMA component, is a new molecular entity. A New Drug Application for UMEC inhalation powder (monotherapy) was submitted to the US FDA on April 30. Vilanterol (VI), the LABA component, is a component of the inhaled corticosteroid (ICS)/LABA combination product containing fluticasone furoate (FF) and VI (Breo Ellipta [fluticasone furoate/vilanterol inhalation powder]). Breo Ellipta received approval by the US FDA for the treatment of COPD in the spring ( The Pharma Letter May 13). Vilanterol is not currently approved for marketing as a monotherapy. An NDA in support of Anoro Ellipta for the long-term, once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema, was submitted to the FDA in December 2012.