Circassia Pharmaceuticals has announced that the United States Food and Drug Administration (FDA) has confirmed it has completed its validation for completeness, and accepted for filing and review, the previously submitted Duaklir new drug application (NDA). The FDA has also accepted for review the Tudorza supplemental NDA (sNDA).
Circassia is a specialty pharmaceutical company focused on respiratory disease.
Duaklir is used in the treatment of chronic obstructive pulmonary disease (COPD). It is a fixed-dose combination of the long-acting muscarinic antagonist (LAMA) aclidinium and the long-acting beta agonist (LABA) formoterol.
The FDA have requested the inclusion of new clinical data demonstrating cardiovascular safety for the Tudorza supplement and the reduction of COPD exacerbations in the product’s prescribing information. Tudorza’s sNDA includes data from the recently completed phase IV ASCENT study. The study, which was conducted in patients with moderate to very severe COPD and cardiovascular disease and / or risk factors, demonstrated Tudorza is effective at reducing COPD exacerbations with no increase in cardiovascular events and reducing hospitalisations due to COPD exacerbations, in this at-risk population.
The FDA confirmed target action dates of 31 March 2019 for completion of the review of both filings under the Prescription Drug User Fee Act (PDUFA).
Steve Harris, Circassia’s CEO, said: “The acceptance of the Duaklir and Tudorza filings is an important milestone for Circassia and we look forward to the outcome of the FDA’s reviews in the coming months. We believe that based on its broad clinical database, Duaklir, if approved, has the potential to become an important new treatment option for COPD patients in the United States."
"In addition, the inclusion of clinical data in Tudorza’s prescribing information demonstrating cardiovascular safety and reductions in COPD exacerbations, if approved, would provide physicians with unique new information.”
