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FDA Accepts Theravance & Mylan’s NDA for Review

The NDA is for an investigational long-acting muscarinic antagonist (LAMA)

By: Betsy Louda

, Contract Pharma

Theravance Biopharma and Mylan announced that the U.S. Food and Drug Administration (FDA) has accepted the companies’ recently submitted New Drug Application (NDA) for revefenacin (TD-4208) for review.  

 

If approved, revefenacin would be the first once-daily, nebulized bronchodilator for the treatment of chronic obstructive pulmonary disease (COPD). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 13, 2018.

 

“The acceptance of our NDA moves us closer to providing COPD patients with access to once-daily, nebulized LAMA therapy. With positive results in our Phase 3 program, we believe that revefenacin is well positioned to fill this important need,” said Rick E Winningham, chairman and chief executive officer of Theravance Biopharma. “I commend the team at Theravance Biopharma and Mylan for producing a high quality submission, and we look forward to working with the FDA in its review of our application.”

 

Theravance Biopharma and Mylan previously reported that in two replicate pivotal Phase 3 efficacy studies, revefenacin demonstrated statistically significant and clinically meaningful improvements as compared to placebo in trough forced expiratory volume in one second (FEV1) and in overall treatment effect on trough FEV1 (OTE FEV1) after 12 weeks of dosing.

 

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