Theravance Announces Publication of YUPELRI® (revefenacin) Area Under the Curve Spirometry Analysis in the International Journal of Chronic Obstructive Pulmonary Disease
"Where previous data showed that revefenacin significantly improved peak and trough FEV
1
at Day 85 compared with placebo in patients with moderate-to-very-severe COPD, this subset post-hoc analysis depicts a more comprehensive view of 24-hour bronchodilation as assessed by examining AUC over multiple time periods," said Dr.
Dr.
Key Study Findings:
- Analysis of a retrospective, pooled sub-study from Phase 3 Studies 0126 and 0127 demonstrated that revefenacin (n = 50) improved bronchodilation versus placebo (n = 47) in patients with moderate-to-very-severe COPD when assessed by FEV1 AUC.
- Rapid onset of bronchodilation was observed, with a mean FEV1 difference of 145 mL achieved at 15 minutes, exceeding the accepted Minimal Clinically Important Difference (MCID) of 100 mL with approximately 97.5% confidence.
- Day 84 bronchodilation improvements were sustained over 24 hours vs. placebo, with mean differences of 282 mL, 220 mL, 205 mL and 212 mL for FEV1 AUC0–2h, AUC0–12h, AUC12–24h and AUC0–24h, respectively, (p<0.001 for all).
Trough FEV1 is an important endpoint often used in COPD trials and provides the magnitude of lung function benefit at the end of a given dosing interval. FEV1 AUC measurements provide additional information on the magnitude and consistency of bronchodilation throughout the dosing interval, including both daytime and nighttime effects. As patients depend on the magnitude of sustained bronchodilation to address COPD symptoms, combined use of both trough FEV1 and FEV1 AUC may allow for a more comprehensive assessment of bronchodilator efficacy to support clinical decision-making.
About Studies 0126 and 0127
Studies 0126 (placebo, n = 209; 88 mcg revefenacin, n = 212; and 175 mcg revefenacin, n = 198), and 0127 (placebo, n = 208; 88 mcg revefenacin, n = 205; and 175 mcg revefenacin, n = 197) were replicate Phase 3 studies which included adults ≥40 years old with documented moderate-to-very-severe COPD, and a current or past smoking history of ≥10 pack-years. Subjects were randomized 1:1:1 to receive revefenacin 88 mcg, revefenacin 175 mcg, or placebo administered once-daily in the morning by a standard jet nebulizer (PARI LC Sprint) for 12 weeks. The prespecified primary efficacy endpoint was change from baseline in trough FEV1 on Day 85. Peak FEV1 on Day 1 was a secondary endpoint and FEV1 AUC from 0 to 2 hours (FEV1 AUC0–2h) on Days 1, 15, 29, 57, and 84 was a prespecified exploratory endpoint1. While both revefenacin 88 mcg and 175 mcg doses were investigated in these trials, the post hoc analysis reported herein focused only on the 175 mcg dose as this is the dose approved by the FDA2.
About YUPELRI
YUPELRI® (revefenacin) inhalation solution is the first and only once-daily nebulized long-acting muscarinic antagonist (LAMA) approved for the maintenance treatment of COPD in the
Important Safety Information
What is YUPELRI®?
- YUPELRI is a prescription medicine used to treat chronic obstructive pulmonary disease (COPD), a long-term (chronic) lung disease that includes chronic bronchitis, emphysema, or both.
- It is an anticholinergic medicine which helps the muscles around the airway in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath.
- It is used long-term as 1 vial of YUPELRI, 1 time each day inhaled through your nebulizer to improve symptoms of COPD for better breathing.
Who should not use YUPELRI?
- Do not use YUPELRI if you have sudden breathing problems. Always have a rescue inhaler with you.
- Do not use YUPELRI if you have had an allergic reaction to revefenacin, or any of the other ingredients in YUPELRI (sodium chloride, citric acid, sodium citrate).
- Do not use in children. It is not known if YUPELRI is safe and effective in children.
Before using YUPELRI, tell your healthcare provider about all your medical conditions, including if you:
- have eye problems such as glaucoma. YUPELRI may make your glaucoma worse.
- have prostate or bladder problems, or problems passing urine. YUPELRI may make these problems worse.
- have liver problems.
- are allergic to any of the ingredients in YUPELRI, or any other medicines.
- are pregnant or planning to become pregnant. It is not known if YUPELRI may harm your unborn baby.
- are breastfeeding. It is not known if the medicine in YUPELRI passes into your breast milk and if it can harm your baby.
Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. YUPELRI and certain other medicines may interact with each other. This may cause serious side effects.
Especially tell your healthcare provider if you take:
- Other anticholinergics (including tiotropium, ipratropium, aclidinium, umeclidinium, glycopyrrolate)
- Atropine
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.
What are the possible side effects with YUPELRI?
YUPELRI can cause serious side effects, including:
- Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using YUPELRI and call your healthcare provider right away.
- New or worsened eye problems including acute narrow-angle glaucoma. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms may include:
- Red eyes
- Blurred vision
- Seeing halos or bright colors around lights
- Eye pain or discomfort
- Nausea or vomiting
- Urinary retention. People who take YUPELRI may develop new or worse urinary retention. Symptoms of urinary retention may include:
- difficulty urinating
- urinating frequently
- urination in a weak stream or drips
- painful urination
If you have any of these symptoms, call your healthcare provider right away before taking another dose.
- Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
- rash
- hives
- severe itching
- swelling of your face, mouth, and tongue
- difficulty breathing or swallowing
If you have any of these symptoms, stop taking YUPELRI, and call your healthcare provider right away before taking another dose.
- Common side effects of YUPELRI include:
- Cough
- Runny nose
- Upper respiratory tract infection
- Headache
- Back pain
Tell your healthcare provider if you get any side effects that bother you or that do not go away. These are not all the possible side effects with YUPELRI. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
How should I use YUPELRI?
Read the step by step instructions for using YUPELRI in the FDA-approved Prescribing Information and in the Patient Information Leaflet
- YUPELRI is only for use with a nebulizer.
- Do not use YUPELRI more often than prescribed.
- Do not mix YUPELRI with other medicines in your nebulizer.
- Do not use other medicines that contain an anticholinergic for any reason.
- Do not stop using YUPELRI, even if you are feeling better, unless your healthcare provider tells you to because your symptoms might get worse.
- Call your healthcare provider or get emergency medical care right away if
- your breathing problems get worse.
- you need to use your rescue inhaler medicine more often than usual.
- your rescue inhaler medicine does not relieve your symptoms.
This summary does not include all the information about YUPELRI and is not meant to take the place of a discussion with your healthcare provider about your treatment.
Please see the full prescribing information and instructions for use at www.yupelri.com
About Theravance Biopharma / Viatris Collaboration
Theravance Biopharma and Viatris Inc. and their respective affiliates have established a strategic collaboration to develop and commercialize nebulized revefenacin products for COPD.
About
For more information, please visit www.theravance.com.
YUPELRI® is a registered trademark of Mylan Specialty L.P., a Viatris company. Trademarks, trade names or service marks of other companies appearing in this press release are the property of their respective owners.
Forward-Looking Statements
This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events.
Contact:
investor.relations@theravance.com
650-808-4045
1Ferguson GT, Feldman G, Pudi KK, et al. Improvements in lung function with nebulized revefenacin in the treatment of patients with moderate to very severe COPD: results from two replicate Phase III clinical trials. Chronic Obstr Pulm Dis
2 YUPELRI (revefenacin). Package Insert.
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