FDA approves GlaxoSmithKline, Theravance's COPD therapy Breo Ellipta

The FDA on Friday approved GlaxoSmithKline and Theravance's Breo Ellipta (fluticasone/vilanterol) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). The clearance of the inhaled drug, which is also indicated for the reduction of exacerbations in patients with a history of COPD exacerbations, follows a positive recommendation by an advisory committee in April. Shares in Theravance rose more than 14 percent on the news.

The FDA's decision was based on study data from 7700 patients with a clinical diagnosis of COPD, showing that those treated with Breo Ellipta displayed improved lung function and reduced exacerbations compared to placebo. The regulator said that the drug will carry a boxed warning indicating that long-acting beta-agonists such as vilanterol are associated with an increased risk of asthma-related death. Theravance indicated that the product will be available in the US during the third quarter.

Analysts project that Breo Ellipta could generate annual sales of $559 million by 2015. GlaxoSmithKline and Theravance submitted the combination therapy for approval in the EU last year, where if approved it will be sold as Relvar. Additionally, the drugmakers have submitted another COPD therapy, Anoro Ellipta (umeclidinium bromide/vilanterol), for approval in the US, Europe and Japan.

In April, Theravance announced plans to split into two companies, with one unit, named Royalty Management, focusing on respiratory drugs under development with GlaxoSmithKline (for related analysis, read ViewPoints: Trouble in paradise – where next for GlaxoSmithKline and Theravance?).

For additional analysis, read ViewPoints: FDA approval now more likely for GlaxoSmithKline’s Breo Ellipta but commercial challenges await and Physician Views Poll Results – US Pulmonologists keen for Breo Ellipta – can payers be convinced?

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