FDA reviews Theravance Biopharma and Mylan N.V NDA for Revefenacin

Theravance Biopharma and Mylan N.V confirmed U.S Food and Drug Administration‘s acceptance for reviewing the company’s New Drug Application (NDA) for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA). Revefenacin is a nebulized bronchodilator for the treatment of chronic obstructive pulmonary disease.

Theravance Biopharma and Mylan previously suggested 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

Rick E Winningham, chairman and chief executive officer of Theravance Biopharma said “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.”

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 13, 2018, and indicated that it does not currently plan to convene an advisory committee meeting to discuss the NDA.