Theravance Biopharma and Mylan to Present New Data on YUPELRI® (revefenacin) at the 2019 CHEST Annual Meeting
DUBLIN and HERTFORDSHIRE, England and PITTSBURGH,
YUPELRI and PERFOROMIST are indicated for the maintenance treatment of COPD. Neither product should be initiated in patients with acutely deteriorating COPD. YUPELRI should be used with caution in patients with narrow angle glaucoma or in patients with prostatic hyperplasia or bladder-neck obstruction. PERFOROMIST should not be used as monotherapy for asthma due to an association with asthma related death. See the full prescribing information for complete information about these products.
Details of the presentations at CHEST 2019 are as follows:
Tolerability and Efficacy of Revefenacin When Administered With Formoterol via Nebulization
- Poster Number: E1085
Tuesday, October 22, 2019, 1:55 – 2 p.m. CT
- Session: 4336
- Location: Exhibit Hall, Poster Area 4
Predictors of Suboptimal Peak Inspiratory Flow Rate in Patients With Chronic Obstructive Pulmonary Disease: Analyses From the Revefenacin Phase 3 Program
- Poster Number: E1081
Tuesday, October 22, 2019, 1:35 – 1:40 p.m. CT
- Session: 4336
- Location: Exhibit Hall, Poster Area 4
COPD is a growing and devastating disease that is the third leading cause of death in the U.S.1 Nearly 15.7 million Americans (6.4%) report that they have been diagnosed with COPD and more are believed to be undiagnosed.2 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
YUPELRI is a registered trademark of
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.
Please see the full Prescribing Information.
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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.
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This press release includes statements that constitute "forward-looking statements," including with regard to the outcome of clinical trials. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such statements. Factors that could cause or contribute to such differences include, but are not limited to any changes in, interruptions to, or difficulties with Mylan's or its partners' ability to develop, manufacture, and commercialize products; the effect of any changes in Mylan's or its partners' customer and supplier relationships and customer purchasing patterns; other changes in third-party relationships; the impact of competition; changes in the economic and financial conditions of the businesses of Mylan or its partners; the scope, timing, and outcome of any ongoing legal proceedings and the impact of any such proceedings on Mylan's or its partners' business; any regulatory, legal, or other impediments to Mylan's or its partners' ability to bring products to market; actions and decisions of healthcare and pharmaceutical regulators, and changes in healthcare and pharmaceutical laws and regulations, in
American Lung Association. "Chronic Obstructive Pulmonary Disease (COPD)" http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/copd. Accessed on August 30, 2019. Center for Disease Control, COPD https://www.cdc.gov/copd/index.html. Accessed on August 30, 2019.
- TBPH market research (N=160 physicians); Refers to US COPD patients.
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