Circassia Announces Publication of Tudorza Phase IV ASCENT Study in the Journal of the American Medical Association
Oxford, UK – 8 May 2019: Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the full publication of the Tudorza® phase IV ASCENT study in the prestigious Journal of the American Medical Association*.
The ASCENT study was conducted in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD) and cardiovascular disease and / or significant cardiovascular risk factors. This patient population is of particular relevance as cardiovascular disease is the most common and significant comorbidity of COPD, with approximately 30% of COPD patients dying from cardiovascular conditions. The ASCENT results demonstrate Tudorza® is effective at reducing COPD exacerbations with no increase in major cardiovascular events, and at reducing hospitalisations due to COPD exacerbations, in this at-risk population.
At the end of March 2019, the FDA approved a supplemental New Drug Application (sNDA) adding these clinical data to Tudorza®’s prescribing information. As a result, Tudorza® is the only long-acting muscarinic antagonist (LAMA) in the United States with COPD exacerbation reduction data and data demonstrating cardiovascular safety in patients with cardiovascular disease / risk factors in its label.
Steve Harris, Circassia’s CEO, said: “The publication of these clinical results in the prestigious Journal of the American Medical Association further demonstrates Tudorza®’s safety and efficacy, particularly in this group of at-risk patients. We are delighted at this recognition of the importance of these data, and of the recent inclusion of this new information in Tudorza®’s prescribing information.”
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