GlaxoSmithKline, Theravance submit US, EU filings for COPD, asthma combination drug

GlaxoSmithKline and Theravance announced Friday the submission of regulatory filings for a combination therapy containing the inhaled corticosteroid fluticasone and the long-acting beta-agonist (LABA) vilanterol in the US and Europe for patients with chronic obstructive pulmonary disease (COPD). The companies also said they filed an application for approval of the once-daily medicine for the treatment of asthma in the EU, adding that they "are reviewing the strategy for a future US filing" in this indication.

In March, GlaxoSmithKline and Theravance reported late-stage clinical data for the combination therapy, noting at the time that regulatory filings would be made later in 2012. The investigational medicine, previously known as Relovair, will be marketed, if approved, as Breo in the US and as Relvar in Europe. The therapy will be administered using a new dry powder inhaler called Ellipta.

The drugmakers noted that the US filing is for the long-term once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema and to reduce exacerbations of COPD in patients with a history of exacerbations. In Europe, the submission is for the symptomatic treatment of patients with COPD with a FEV1 of less than 70 percent of the predicted normal value for patients with an exacerbation history.

Meanwhile, GlaxoSmithKline and Theravance indicated that the second filing in Europe is for the regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product comprising a LABA and inhaled corticosteroid is appropriate.

GlaxoSmithKline and Theravance are also developing vilanterol in combination with the long-acting muscarinic antagonist umeclidinium bromide, and announced positive late-stage results from four studies of the therapy earlier this month.

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