Circassia Announces FDA Approval of Tudorza Supplemental New Drug Application

Data showing reduction in COPD exacerbations and no increase in major cardiovascular events vs placebo added to label –
– Tudorza® is the only product in its class with these data in the label

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.

About Circassia
Circassia is a world-class specialty pharmaceutical business focused on respiratory disease. The Company sells its novel, market-leading NIOX® asthma management products directly to specialists in the United States, United Kingdom, China and Germany, and in a wide range of other countries through its network of partners.  In the United States, Circassia has a commercial collaboration with AstraZeneca in which it has the commercial rights to chronic obstructive pulmonary disease (COPD) treatments Tudorza® and Duaklir®.  Circassia also has the US and Chinese commercial rights to the late-stage ventilator-compatible nitric oxide product AirNOvent.