Theravance Biopharma and Mylan have announced positive results from two replicate Phase 3 studies of revefenacin (TD-4208) for the treatment of chronic obstructive pulmonary disease (COPD). The two studies met their primary endpoints of demonstrating statistically significant improvements over placebo in trough forced expiratory volume in one second (FEV1).

“These data confirm that revefenacin has the potential to offer meaningful benefits to patients with moderate to very severe COPD,” said Brett Haumann, MD, CMO at Theravance Biopharma.

Revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA), is the first once-daily, nebulized bronchodilator in development for COPD. The studies included a combined total of 1,250 patients with moderate to very severe COPD and lasted for 12 weeks. Groups were divided into two dosing groups: 88mcg and 175mcg. 

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The pre-specified pooled analyses results showed that revefenacin produced increases in trough FEV1 in a subgroup (38%) of patients using background long-acting beta agonist (LABA) therapy and in a subgroup of patients who were not using concomitant LABA therapy, when compared to placebo. The LABA subgroup had FEV1 improvements of 92mL and 135mL for the 88mcg and 175mcg doses, respectively. For the non-LABA group the improvements were greater, at 131mL and 150mL for 88mcg and 175mcg, respectively.

Both doses were generally well tolerated, with comparable rates of adverse events (AEs) between the active and placebo groups. The most commonly reported AEs were exacerbations, cough, dyspnea and headache.

A safety study of revefenacin (TD-4208) is currently ongoing in more than 1,050 patients, and is expected to finish in 2017. Based on the outcomes of the safety study, Theravance expects to file a new drug application (NDA) to the Food and Drug Administration by the end of 2017.

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