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US Filing of Duaklir NDA & Tudorza Supplement NDA
US Filing of Duaklir NDA & Tudorza Supplement NDA.
About this update from Niox Group Plc
[{"type":"text","content":"\n \nRNS Number : 9346P Circassia Pharmaceuticals Plc 01 June 2018 \n\nCircassia Announces Submission of Duaklir® New Drug Application and Tudorza® Supplemental New Drug Application in the United States\n \nØ Duaklir® NDA for treatment of chronic obstructive pulmonary disease (COPD)\n \nØ Tudorza® sNDA for inclusion of COPD exacerbation reduction and cardiovascular safety data in label\n \nOxford, UK - 1 June 2018: Circassia Pharmaceuticals plc (\"Circassia\" or \"the Company\"; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for Duaklir® Pressair® for the treatment of chronic obstructive pulmonary disease (COPD). \n \nThe Company also announces the concurrent submission of a supplemental New Drug Application (sNDA) for Tudorza® Pressair® for the inclusion of clinical data demonstrating cardiovascular safety and reduction of COPD exacerbations in the product's prescribing information. \n \nUnder the Prescription Drug User Fee Act (PDUFA), the review period for the NDA and sNDA will be confirmed in the Day 74 communication from the FDA. \n \nSteve Harris, Circassia's CEO, said: \"The regulatory submissions for Duaklir® and Tudorza® represent a major milestone for Circassia, coming just one year after we established our transformational collaboration for their commercialisation with AstraZeneca. We believe that Duaklir®, if approved, has the potential to provide an important treatment option for the significant number of patients with COPD in the United States. In addition, the positive cardiovascular safety and COPD exacerbation reduction results achieved in the Tudorza® ASCENT study offer the potential to include unique new information in the product's prescribing information, if approved.\"\n \nAbout Duaklir® Pressair®\nDuaklir® is a fixed-dose combination of the long-acting muscarinic antagonist (LAMA) aclidinium and the long-acting beta agonist (LABA) formoterol. It is administered twice daily via the easy-to-use, breath-actuated, multi-dose inhaler, Pressair®. The product is approved in approximately 50 countries worldwide, including in the European Union, under a number of brand names. In April 2017, C...