Theravance’s Revefenacin On Track For 2017 Filing With Success In Two Pivotal Trials

Partnered with Mylan to bring the first once-daily nebulized LAMA bronchodilator to market for COPD, Theravance reports statistical significant in two Phase III studies and now awaits data expected next year from an open-label safety study.

Theravance Biopharma Inc. and partner Mylan NV are on pace to submit an NDA for revefenacin – which they say would be the first once-daily nebulized bronchodilator for chronic obstructive pulmonary disease – in late 2017, having announced that a pair of replicate Phase III studies have met their primary endpoints.

The companies are counting on the once-daily, nebulized formulation to distinguish revefenacin in the crowded COPD market, but they will have to compete with another nebulized option. Sunovion Pharmaceuticals Inc. announced on Oct

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