According to Circassia Pharmaceuticals, the FDA has accepted its NDA for the Duaklir aclidinium/formoterol DPI for the treatment of COPD and an sNDA for the Tudorza aclidinium bromide DPI, with a PDUFA date of March 31, 2019 for both applications. The Tudorza sNDA requests to add COPD exacerbation reductions and cardiovascular safety data to the prescribing information.
Tudorza Pressair was approved by the FDA in 2012 for the treatment of COPD. In Europe, the inhaler has also been approved – as Eklira Genuair or Bretaris Genuair – since 2012. Duaklir has been approved in Europe since 2014.
Circassia acquired US rights to both products from AstraZeneca in 2017. AstraZeneca acquired the US rights to the inhalers from Actavis in 2015.
Circassia CEO Steve Harris commented, “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.”
Read the Circassia Pharmaceuticals press release.
