Theravance Reports Positive Data From Phase 3 Program For YUPELRI Solution

(RTTNews) - Theravance Biopharma, Inc. (TBPH) and Mylan N.V. (MYL) announced that the data from a Phase 3 clinical program for YUPELRI inhalation solution showed reductions in the rates of chronic obstructive pulmonary disease exacerbations ranging from 15% to 18% in moderate to very severe COPD patients administered once-daily YUPELRI for up to 52 weeks as compared to placebo and tiotropium.

YUPELRI is an investigational long-acting muscarinic antagonist currently under review by the U.S. FDA for the treatment of COPD. The PDUFA date for YUPELRI is November 13, 2018. The company noted that, while the YUPELRI Phase 3 program was not designed or powered to achieve statistical significance on differences in COPD exacerbation rates, researchers were interested in a post-hoc analysis of data from the studies to identify trends in this area.

Rick Winningham, CEO of Theravance Biopharma, said: "While not necessary for potential FDA approval, these COPD exacerbations data provide us with important additional context regarding the potential therapeutic profile of YUPELRI, which we and our partner Mylan believe can serve as an important once-daily treatment option for COPD patients who need or prefer nebulized therapy."