BRIEF—Circassia announces Duaklir and Tudorza NDAs

The US Food and Drug Administration (FDA) announced on Monday that it had accepted a New Drug Application for Circassia Pharmaceuticals' Duaklir (aclidinium/formoterol).

A supplemental NDA was also accepted by the agency for Tudorza (aclidinium), to include the latest new clinical data on the drug's performance in treating chronic obstructive pulmonary disease (COPD).

Steve Harris, Circassia chief executive, 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 USA.  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.”