The U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application for the addition of new clinical data on on the label of Tudorza (aclidinium bromide), a bronchodilator for the long-term treatment of chronic obstructive pulmonary disease (COPD) marketed by Circassia Pharmaceuticals in the U.S.
Tudorza’s label will now include new data from the ASCENT study, a Phase 4 clinical trial (NCT01966107) designed to assess the safety and effectiveness of Tudorza in COPD patients who also had cardiovascular problems (heart disease) or were at a high risk of developing it — a common condition among COPD patients.
ASCENT enrolled a total of 3,635 patients with moderate to very severe COPD who were treated with 400 micrograms of Tudorza or a placebo, twice a day via the Pressair inhaler, for up to 36 months.
Clinical data showed that patients on Tudorza experienced fewer COPD flares (exacerbations) and required fewer hospitalizations than those on the placebo. Importantly, the treatment was found to not increase the risks of cardiovascular events among high-risk patients.
The addition of this information on Tudorza’s label makes it the only long-acting muscarinic antagonist (LAMA)-based product currently on the market featuring cardiovascular risk-related data.
“This approval adds unique new clinical data to Tudorza’s label, which further differentiates this important COPD treatment option within the $2 billion U.S. LAMA market,” Steve Harris, CEO of Circassia, said in a press release.
“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,” he said.
Like Duaklir, another long-term maintenance treatment for COPD that has been recently approved by the FDA, Tudorza works by increasing the size of patients’ airways to facilitate breathing. It does so by blocking muscarinic receptors using its active principle — aclidinium bromide, a LAMA — that triggers relaxation of smooth muscles surrounding the airways.
Both medications are recommended to be taken twice daily, using the Pressair inhaler, a device that should be placed in the patient’s mouth to dispense precise amounts of the medication that are then inhaled.
In 2017, Circassia signed a collaboration agreement with AstraZeneca to develop and commercialize both Tudorza and Duaklir in the U.S. By the end of last year, Circassia had acquired the full commercial rights for both medications in the U.S.
“Following our recent option exercise acquiring the full U.S. commercial rights to Tudorza, and this subsequent label expansion, we look forward to implementing our strategy targeting product growth in this major market,” Harris said.