US drug developer Theravance Biopharma (Nasdaq: TBPH) and Netherlands-headquartered Mylan (Nasdaq: MYL) announced new data on their already USA-approved drug Yupelri (revefenacin) that further enforces the drug’s potential study at the 2019 American Thoracic Society (ATS) International Conference in Dallas, Texas.
Yupelri inhalation solution, a long-acting muscarinic antagonist (LAMA), is the first and only once-daily, nebulized bronchodilator approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in the USA, effective November 2018.
Researchers presented a subgroup analysis of data from the revefenacin Phase III program of patients treated concurrently with long-acting beta agonists (LABA) either with or without inhaled corticosteroids (ICS). A pre-specified subgroup analysis was conducted on pooled data from two 12-week replicate placebo-controlled trials (n=812). Separately, exploratory endpoint data from a 52-week randomized, tiotropium-controlled safety trial were analyzed (n=670). Overall, an average of 43% of patients across the three studies were using concurrent LABA or LABA/ICS combination therapy. This subgroup had more severe disease at baseline.
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