The FDA accepted Theravance Biopharma and Mylan’s nebulized chronic obstructive pulmonary disease drug for review, with a PDUFA date of Nov. 13. If cleared, revefenacin would be the first once-daily, nebulized bronchodilator for COPD.
Revefenacin, a nebulized long-acting muscarinic antagonist (LAMA), has had a checkered past—GlaxoSmithKline acquired the rights to revefenacin in 2004 but ditched the candidate after discovering its formulation was incompatible with its proprietary inhaler.
Without missing a beat, Theravance repositioned the drug as a nebulized product and the company now considers this a distinguishing feature.
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"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, in a statement.
“With positive results in our Phase 3 program, we believe that revefenacin is well positioned to fill this important need," said Rick Winningham, Theravance CEO. "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."
In July, the companies reported 12-month safety data from two phase 3 trials that showed revefenacin has a similar safety profile to Boehringer Ingelheim’s Spiriva; the data followed positive efficacy data from a pair of shorter phase 3 studies.
While Theravance and Mylan pitted their drug against Spiriva, Verona Pharma took a complementary approach—in September, the U.K.-based company unveiled phase 2a data that showed combining its RPL554 with Spiriva improved lung function in patients with COPD.