TUDORZA® PRESSAIR® Supplemental New Drug Application Approval Includes Data for Reduction of COPD Exacerbations and Hospitalizations

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Label Updated to Include Reduction in Exacerbations and Major Adverse Cardiovascular Event Safety Data in Cardiovascular-Risk COPD Patients

Circassia Pharmaceuticals Inc. (“Circassia” or “the Company”), recently announced that the US Food and Drug Administration (FDA) added new data to the TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) Prescribing Information that includes data from the ASCENT trial showing that TUDORZA PRESSAIR reduces exacerbations in chronic obstructive pulmonary disease (COPD) and does not increase major adverse cardiovascular events (MACE) in COPD patients with cardiovascular disease and/or significant cardiovascular risk factors.1TUDORZA PRESSAIR is indicated for the maintenance treatment of patients with COPD.2

According to Kenneth Chapman, MD, Clinical Researcher, Krembil Research Institute, University Health Network, University of Toronto, and investigator on the ASCENT trial: “Most people who have COPD are also at a higher risk for cardiovascular disease because the most common cause of COPD is long-term smoking. The ASCENT trial was important because it looked at people who are in this high-risk cardiovascular category. For a very long time, patients with a high cardiovascular risk were excluded from long-acting muscarinic antagonist (LAMA) trials, so we were unclear about the effect of LAMAs on cardiovascular disease; confidence has been low and questions about its safety have lingered. ASCENT showed that TUDORZA PRESSAIR use led to clear and consistent reduction in exacerbations and reductions in flare-ups. This leads to lower emergency room visits and lower hospital admissions.”

COPD exacerbations, or “flare-ups,” include a sudden worsening of symptoms such as shortness of breath, worsened cough, headaches.3 Frequent exacerbations accelerate disease progression and death.4 Exacerbations also lead to increased unscheduled physician and emergency room visits, which can add to the financial burden of COPD on individuals and the healthcare system.5

“It was essential to answer the question about major adverse cardiovascular events and safety in COPD patients with cardiovascular co-morbidity. The inclusion of the ASCENT safety information in the updated TUDORZA PRESSAIR label addresses that question,” said Michael Asmus, Vice President, US Medical Affairs, Circassia. “Exacerbations are also serious, and sometimes life-threatening events, and it’s gratifying to make a difference in helping to improve the lives of people who live with COPD.”

“The expanded label for TUDORZA PRESSAIR is welcome news for the COPD community and providers who care for COPD patients,” said David Acheson, Senior Vice President, US Commercial, Circassia. “Circassia is proud to be a leader in the respiratory health space, and today’s news further demonstrates our commitment to respiratory health.”

ASCENT was a randomized, double-blind, placebo-controlled of up to 36-months study that evaluated the effect of TUDORZA PRESSAIR on MACE and exacerbations in 3,630 patients with moderate-to-very-severe COPD.6 All patients had a history of cardiovascular or cerebrovascular disease and/or significant cardiovascular risk factors.This phase IV trial found that, compared to placebo, TUDORZA PRESSAIR does not increase MACE and reduced exacerbations in the first year in COPD patients with high cardiovascular risk.1 TUDORZA PRESSAIR is not a rescue medicine and should not be used for treating sudden breathing problems.2 In this study, adverse reactions occurring at a rate of ≥2% and more common than placebo were nausea, back pain, cough, hypertension, sinusitis, constipation, arthralgia, anemia, muscle spasms, cardiac failure congestive, cellulitis, and gastroesophageal reflux disease.2

Please see complete Important Safety Information below and full prescribing information here.2


1. Wise RA, et al. Effects of aclidinium bromide on major adverse cardiovascular events and COPD exacerbations in patients with COPD and cardiovascular risk factors. Am J Respir Crit Care Med 2018;197:A7711.

2. TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.

3. COPD Foundation. “Avoiding COPD Exacerbations.” https://www.copdfoundation.org/Learn-More/I-am-a-Person-with-COPD/Avoiding-Exacerbations-and-Pneumonia.aspx Accessed March 14, 2019.

4. Halpin DMG, et al. Exacerbation frequency and course of COPD. Int J Chron Obstruct Pulmon Dis. 2012;7:653-661.

5. Dhamane AD, et al. COPD exacerbation frequency and its association with health care resource utilization and costs. Int J Chron Obstruct Pulmon Dis. 2015;10:2609-2618.

6. Wise RA, et al. Long-term evaluation of the effects of aclidinium bromide on major adverse cardiovascular events and COPD exacerbations in patients with moderate to very severe COPD: rationale and design of the ASCENT COPD study. Chronic Obstr Pulm Dis. 2018;5(1):5-15.

7. World Health Organization. Chronic Obstructive Pulmonary Disease (COPD) Fact Sheet. December 1, 2017. https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd) Accessed March 15, 2019.

8. American Lung Association. https://www.lung.org/lung-health-and-diseases/lung-disease-lookup/copd/learn-about-copd/how-serious-is-copd.html Accessed March 15, 2019.

Source: Business Wire

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