FDA approves once-daily COPD drug Breo
Theravance Inc. (NASDAQ:THRX) gained $3.63 (12%) to $34.94 on Friday after FDA approved an NDA from partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for Breo Ellipta fluticasone furoate/vilanterol as maintenance therapy for airflow obstruction in patients with chronic obstructive pulmonary disease. FDA also approved the drug to reduce exacerbations of COPD in patients with a history of exacerbations. The approval triggered a $30 million milestone payment to GSK from Theravance. GSK said it plans to launch Breo Ellipta next quarter, but did not disclose the price.
Breo's label includes a boxed warning that long-acting adrenergic receptor beta 2 agonists (LABAs) increase the risk of asthma-related death. The product is a once-daily, fixed-dose combination of an inhaled corticosteroid and vilanterol, which is a LABA, delivered once-daily via the dry powder Ellipta inhaler. The product is under review in the EU under the trade name Relvar Ellipta to treat asthma and COPD (see BioCentury, April 22). ...