Pivotal phase III trial of Yupelri shows additional control of COPD

Theravance Biopharma and Mylan announced the presentation of data from its pivotal Phase III efficacy studies and a 52-week safety study of Yupelri (revefenacin) inhalation solution, a long-acting muscarinic antagonist (LAMA), once-daily, nebulized bronchodilator approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in the US. 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 prespecified 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. The results suggest the use of Yupelri with LABA or ICS/LABA may provide additional COPD symptom control particularly in patients with more severe disease, though additional studies are needed to confirm any such benefit.

In the analysis of the pooled data (studies 126 and 127), the once daily nebulized treatment with revefenacin produced greater improvements from baseline compared with placebo (p <0.0001) in day 85 trough FEV1 among the non-LABA and LABA subgroups. Additionally, a clinically significant improvement of an approximately 100-mL increase in trough FEV1 was sustained for 12 weeks for those treated with revefenacin in both the LABA and non-LABA subgroups.

Yupelri is a long-term maintenance therapy and should not be initiated in patients during acutely deteriorating or potentially life-threatening episodes of COPD, use with caution in patients with narrow-angle glaucoma, and worsening of urinary retention may occur. The most common adverse events in clinical trials included cough, nasopharyngitis, upper respiratory infection, headache and back pain. Data were presented at the 2019 American Thoracic Society (ATS) International Conference in Dallas, Texas.

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