FDA approves Theravance and GSK's Breo Ellipta to treat COPD

The US Food and Drug Administration on Friday (May 10) approved Breo Ellipta (fluticasone furoate, an inhaled corticosteroid, and vilanterol inhalation powder, a long-acting beta2-adrenergic agonist), from UK pharma giant GlaxoSmithKline (LSE: GSK) and US biotech firm Theravance (Nasdaq: THRX).

The drug was cleared 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. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations. The FDA decision was largely expected, given the positive backing from the agency’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) last month (The Pharma Letter April 18).

Breo Ellipta sales forecasts range from $560 million to $4 billion