GSK, Theravance seek FDA, European approval of COPD/asthma drug

Theravance CEO Rick Winningham.

Theravance Inc. and partner GlaxoSmithKline are asking regulators to approve a once-a-day treatment for patients with asthma and chronic obstructive pulmonary disease, a potential replacement for GSK's top-selling Advair.

South San Francisco-based Theravance (NASDAQ: THRX) and Glaxo (NYSE: GSK)said Friday that they asked the Food and Drug Administration to approve the drug, which would be branded as Breo, for patients with COPD, a kind of catch-all category for several smoking and environmental-related lung diseases like emphysema and chronic bronchitis.

The companies also are applying to the European Medicines Agency to use the drug, called Relvar in Europe, for treatment of COPD patients and asthma patients aged 12 years and older.