Theravance Biopharma and Mylan have announced that two 12-week Phase 3 efficacy studies of nebulized revefenacin (TD-4208) for the treatment of COPD have met their primary efficacy endpoint of statistically significant increase in FEV1 for both doses studied compared to placebo. Patients receiving the 88 mcg dose averaged a 118 mL increase in tough FEV1 after 12 weeks compared to placebo; the increase for patients receiving the 175 mcg dose averaged a 145 mL increase.
Mylan and Theravance announced that they would partner on development of TD-4208 in February 2015.
The study involved more than 1,250 patients with moderate-to-very severe COPD. A subgroup of patients enrolled in the study who were using LABA therapies averaged increases of 92 mL for the 88 mcg dose and 135 mL for the 175 mcg dose; patients not using a LABA averaged an increase of 131 mL for the 88 mcg dose and 150 mL for the 175 mcg dose. Both doses were well-tolerated with similar rates of adverse events for both doses and the placebo.
Theravance Biopharma Chief Medical Officer Brett Haumann commented, “We are extremely pleased with the outcome of these pivotal Phase 3 efficacy studies. The impressive improvements in FEV1 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. 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.”
Mylan President Rajiv Malik said, “The positive results from these Phase 3 studies represent another exciting milestone in Mylan’s robust global respiratory pipeline. 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.”
Read the Theravance Biopharma and Mylan press release.
