Theravance Biopharma and Mylan have submitted a New Drug Application (NDA) for revefenacin (TD-4208) – a long-acting muscarinic antagonist (LAMA) – as a once-daily, nebulized bronchodilator in development for the treatment of chronic obstructive pulmonary disease (COPD).

The submission is based on two Phase 3 studies and a 12-mouth, open-label, active comparator study. In the Phase 3 trials revefenacin demonstrated statistically significant and clinically meaningful improvements compared to placebo in trough forced expiratory volume in 1 second (FEV1) and in overall treatment effect on trough FEV1 (OTE FEV1) after 12 weeks. The most frequent adverse events were exacerbations, cough, dyspnea and headache. Additionally, the companies have previously announced positive results from the 12-month Phase 3 safety study, which did not identify new safety issues. 

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“While a significant number of COPD patients require or prefer nebulized therapy, these same patients currently have no access to a nebulized LAMA, broadly considered the cornerstone of COPD maintenance therapy,” said Brett Haumann, MD, Chief Medical Officer at Theravance Biopharma.

Theravance Biopharma and Mylan have partnered on the development and commercialization of nebulized revefenacin for COPD and other respiratory diseases. The companies are developing revefenacin for patients with COPD that will be compatible with a range of jet nebulizers.

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