Circassia Announces FDA Approval of Tudorza Supplemental New Drug Application
Oxford, UK – 29 March 2019: Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the US Food and Drug Administration (FDA) has approved Tudorza®’s supplemental New Drug Application (sNDA) for the inclusion of unique new clinical data in the product’s label. Tudorza® is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) and contains the long-acting muscarinic antagonist (LAMA) aclidinium bromide (400 mcg) administered twice-daily via the breath-actuated inhaler Pressair®.
Tudorza®’s expanded label now includes data from the phase IV ASCENT study, which was conducted in patients with moderate to very severe COPD and cardiovascular disease and / or significant cardiovascular risk factors. The study demonstrated that 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. Cardiovascular disease is the most common and significant co-morbidity of COPD, with approximately 30% of COPD patients dying from cardiovascular conditions. Tudorza® is the only LAMA in the United States with these data in its label.
Steve Harris, Circassia’s Chief Executive, said: “This approval adds unique new clinical data to Tudorza®’s label, which further differentiates this important COPD treatment option within the $2 billion US LAMA market. Cardiovascular disease is a major co-morbidity of COPD, and the inclusion of comprehensive data demonstrating COPD exacerbation reductions and cardiovascular safety provides physicians with important new information, helping to further serve this significant patient group. Following our recent option exercise acquiring the full US commercial rights to Tudorza®, and this subsequent label expansion, we look forward to implementing our strategy targeting product growth in this major market.”
Tudorza® is a registered trademark of Almirall S.A.Pressair® is a registered trade mark of the AstraZeneca group of companies
This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation 596/2014. The person who arranged for the release of this announcement on behalf of Circassia was Julien Cotta, Chief Financial Officer.
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