Positive new data from multiple studies of COPD drug Yupelri

US drug developer Theravance Biopharma (Nasdaq: TBPH) and Netherlands-headquartered Mylan (Nasdaq: MYL) today announced that positive new data from multiple studies of Yupelri (revefenacin) inhalation solution were presented at the 2018 CHEST annual meeting, which was held in San Antonio, Texas last week.

Yupelri is an investigational long-acting muscarinic antagonist (LAMA) currently under review by the US Food and Drug Administration for the treatment of chronic obstructive pulmonary disease (COPD). The Prescription Drug User Fee Act (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. The drug 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 (PIFR) (< 60 L/min). 207 subjects were enrolled and randomized to receive either Yupelri (175mcg once daily) or tiotropium once daily for 28 days. Efficacy assessments included forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).