Theravance Biopharma and Mylan N.V. have announced that the US Food and Drug Administration  (FDA) has accepted for review the companies' recently submitted New Drug Application (NDA) for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA). 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, and indicated that it does not currently plan to convene an advisory committee meeting to discuss the NDA.

"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 programme, 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." "Today, patients with moderate to severe COPD do not have access to a nebulized LAMA as a treatment option yet. We believe revefenacin, when approved, represents an important advancement in respiratory care by offering a convenient once-daily option for patients, and further strengthens Mylan's robust and growing respiratory portfolio," said Mylan President Rajiv Malik . "We are extremely pleased that the revefenacin NDA has been accepted for FDA review, as it demonstrates the success of our collaboration with Theravance Biopharma, our collective expertise in complex products and the quality of the revefenacin development program."

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.

Both doses of revefenacin had comparable rates of adverse events (AEs) to placebo, low rates of serious adverse events (SAEs), and no clinically meaningful differences in blood parameters or electrocardiogram (ECG) data, across all treatment groups (active and placebo). As previously reported, the most commonly reported adverse events, across both trials and across all treatment groups, 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. Rates of AEs and SAEs in the study were low and comparable to those seen in the standard of care treatment arm.

Theravance Biopharma and its affiliates have partnered with Mylan and its affiliates on the development and commercialization of nebulized revefenacin products for COPD and other respiratory diseases. The companies are developing revefenacin as a once-daily, nebulized bronchodilator for the treatment of patients with COPD that will be compatible with a range of jet nebulizers.