Theravance Biopharma and Mylan Present Additional YUPELRI® (revefenacin) Phase 3 Data Analysis at the 2019 ATS International Conference
YUPELRI® (revefenacin) 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 U.S.
Safety and Efficacy in Concomitant LABA or ICS/LABA Treatment COPD Patient Subgroup
Researchers presented a subgroup analysis of data from the revefenacin Phase 3 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.
"These findings add to the growing body of evidence that YUPELRI may offer meaningful benefits to a broad range of COPD patients, including those with more severe disease," said
The companies also presented the following two posters at ATS that add to the scientific understanding and potential clinical significance of peak inspiratory flow rate (PIFR) measurements in patients with COPD:
Technical Peak Inspiratory Flow Rate (PIFR) Measurement
PIFR may be an important measurement in deciding whether COPD patients are able to gain full benefit from their handheld inhalers or whether they would be better suited to treatment with a nebulized product. Researchers proposed a method for measuring PIFR in clinical trials that optimizes the repeatability of the measurements and also defines a model to characterize the relationship between PIFR measured using different resistances – the resistance in the DISKUS® device compared with the resistance in the HandiHaler® device. Based on an analysis of data from COPD patients with suboptimal PIFR, researchers suggest that at least three measures of PIFR using the In-Check DIAL device are taken until the two highest measurements meet the repeatability limit for the resistance used (10 L/min against PIFRD and 5 L/min against PIFRHH). Researchers propose using the resistance of the dry powder inhaler (DPI) that the patient is using for treatment at the time when measuring PIFR.
Suboptimal PIFR Associated with Greater Dyspnea
Baseline PIFR to DISKUS® resistance (PIFRD) and severity of dyspnea – the medical term for shortness of breath – were analyzed from two clinical studies. Researchers found that patients with suboptimal PIFRD (<60 L/min) had more severe dyspnea than patients with similar obstruction and optimal PIFRD (≥60 L/min). According to the researchers, the differences in dyspnea observed may represent the effect of inspiratory limitation seen in those with suboptimal PIFRD on their respiratory muscle function, lung hyperinflation or air trapping.
YUPELRI was approved in
COPD is a growing and devastating disease that is the third leading cause of death in the U.S.2 Nearly 15.7 million Americans (6.4%) report that they have been diagnosed with COPD and more are believed to be undiagnosed.3 There were more than 700,000 hospital discharges related to COPD in the U.S. reported in 2010. The costs of managing COPD in the U.S. were estimated to be nearly
YUPELRI® (revefenacin) inhalation solution is a once-daily nebulized LAMA approved for the maintenance treatment of COPD in the U.S. Market research by
Important Safety Information
YUPELRI is contraindicated in patients with hypersensitivity to revefenacin or any component of this product.
YUPELRI should not be initiated in patients during acutely deteriorating or potentially life-threatening episodes of COPD, or for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.
As with other inhaled medicines, YUPELRI can produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs following dosing with YUPELRI, it should be treated immediately with an inhaled, short-acting bronchodilator. YUPELRI should be discontinued immediately and alternative therapy should be instituted.
YUPELRI should be used with caution in patients with narrow-angle glaucoma. Patients should be instructed to immediately consult their healthcare provider if they develop any signs and symptoms of acute narrow-angle glaucoma, including eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema.
Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur.
Immediate hypersensitivity reactions may occur after administration of YUPELRI. If a reaction occurs, YUPELRI should be stopped at once and alternative treatments considered.
The most common adverse reactions occurring in clinical trials at an incidence greater than or equal to 2% in the YUPELRI group, and higher than placebo, included cough, nasopharyngitis, upper respiratory infection, headache and back pain.
Coadministration of anticholinergic medicines or OATP1B1 and OATP1B3 inhibitors with YUPELRI is not recommended.
YUPELRI is not recommended in patients with any degree of hepatic impairment.
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1 "Clinically meaningful" is defined by industry established Minimal Clinically Important Difference (MCID) for lung function (100 mL improvement in FEV1).
2 American Lung Association. "Chronic Obstructive Pulmonary Disease (COPD)" http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/copd. Accessed on
3 Center for Disease Control, COPD https://www.cdc.gov/copd/index.html. Accessed on
4 TBPH market research (N = 160 physicians); Refers to US COPD patients.
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Theravance Biopharma, Jessica Stitt, 650-808-3763, firstname.lastname@example.org ; Mylan, Christine Waller (Media), 724-514-1968; Melissa Trombetta (Investor Relations), 724-514-1813