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Theravance, Mylan Report Positive New Data From Multiple Studies Of Yupelri

Theravance Biopharma, Inc. (TBPH) and Mylan N.V. (MYL) said Thursday that positive new data from multiple studies of Yupelri, or revefenacin inhalation solution were presented at the 2018 CHEST annual meeting, held in San Antonio, Texas from October 6 to 10, 2018.

Yupelri is an investigational long-acting muscarinic antagonist or LAMA currently under review by the U.S. Food and Drug Administration for the treatment of chronic obstructive pulmonary disease or COPD.

The Prescription Drug User Fee Act or PDUFA date for Yupelri is November 13, 2018. If approved, Yupelri would be the first and only once-daily, long-acting nebulized bronchodilator for the treatment of COPD. Yupelri is designed to be compatible with any standard jet nebulizer.

Researchers presented new data from a randomized, double-blinded study comparing the efficacy of Yupelri to tiotropium in patients with moderate to very severe COPD and suboptimal peak inspiratory flow rates.

207 subjects were enrolled and randomized to receive either Yupelri (175 mcg once daily) or tiotropium once daily for 28 days. Efficacy assessments included forced expiratory volume in one second or FEV1, and forced vital capacity or FVC.

In the intent-to-treat population, the Yupelri group showed improvements in trough FEV1 and trough FVC on day 29 compared with tiotropium group, However, these differences did not reach statistical significance.

In pre-specified analyses of data from the Yupelri Phase 3 program, pooled data from the two replicate 12-week pivotal Phase 3 efficacy trials demonstrated that Yupelri dosed at 175 mcg once daily produced greater improvements in trough FEV1 than Yupelri dosed at 88 mcg once daily in each of the four analyzed subgroups.

Researchers also conducted a review of cardiovascular or CV safety data from four clinical studies of Yupelri including the two replicate 12-week pivotal Phase 3 efficacy trials, the 12-month Phase 3 safety trial and a Phase 1 QT study in healthy subjects.

The data analysis demonstrated that once-daily Yupelri dosed for up to 52 weeks did not prolong QT interval or increase risk of major adverse cardiac events, or MACE.

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