The FDA is slated to make a decision about the once-daily treatment by Nov. 13.
“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,” Theravance chairman & CEO Rick Winningham said in prepared remarks. “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 has partnered with Mylan (NSDQ:MYL) to develop and commercialize its nebulized revenfenacin products. According to the terms of the deal, Theravance holds rights to revenfenacin in the U.S., while Mylan has rights outside the U.S. The deal could bring Theravanace as much as $220 million in milestones from Mylan, as well as double-digit royalties on sales outside the U.S. The two companies are slated to share profits made on sales within the States.
“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,” Mylan President Rajiv Malik added. “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.”
In two replicate pivotal Phase III trials, revefenacin showed statistically significant and clinically meaningful improvements after 12 months compared to a placebo. The drug also had comparable rates of adverse events when compared with a placebo.
If approved, the product would compete with Sunovion‘s Sun-101/eFlow drug-device combo – the first nebulized long-acting muscarinic antagonist approved for the treatment of COPD in the U.S. The system includes a portable nebulizer that delivers the drug in two to three minutes and allows the user to breathe normally while the drug is administered.
Sunovion expects its product to be available in pharmacies early this year.