Mylan (NSDQ:MYL) and Theravance Biopharma, Inc. (NSDQ:TBPH) said today that revefenacin, the 1st nebulized bronchodilator in development for the treatment of chronic obstructive pulmonary disease, demonstrated positive results in 2 replicate phase III efficacy studies.
Data from more than 1,250 moderate to severe COPD patients showed that both studies met their efficacy and safety endpoints. Revefenacin demonstrated statistically significant improvements to COPD symptoms over the course of 12 weeks compared to a placebo.
The 2 dosage levels of revenfenacin were well-tolerated, with comparable rates of adverse and serious events across both treatment groups, the companies reported. The most common adverse event were exacerbations, cough, dyspnea, and headache.
“We are extremely pleased with the outcome of these pivotal Phase 3 efficacy studies. The impressive improvements in [forced expiratory volume in one second] have exceeded our expectations, particularly when one considers that in nearly 40% of the patients we added revefenacin to their existing LABA or LABA/ICS therapy. These data confirm that revefenacin has the potential to offer meaningful benefits to patients with moderate to very severe COPD,” Theravance chief medical officer Dr. Brett Haumann said in prepared remarks. “As the first once-daily nebulized bronchodilator of any class in late-stage development, combined with its compatibility with any standard jet nebulizer, revefenacin is uniquely positioned to address a key unmet need in the treatment of COPD. We look forward to completing our ongoing Phase 3 safety trial in 2017, with the goal of filing an NDA by the end of 2017.”
“The positive results from these Phase 3 studies represent another exciting milestone in Mylan’s robust global respiratory pipeline,” Mylan prez Rajiv Malik added. “We are very pleased with our collaboration with Theravance Biopharma and their work advancing this important program, and we look forward to continuing to work together to bring this product to market. We believe Mylan’s strong experience with nebulized products and experienced salesforce in the respiratory segment, which has been further enhanced through our Meda transaction, will help ensure this product’s success if approved.”
