According to Circassia Pharmaceuticals, the FDA has approved the company’s sNDA for the addition of data from the Phase 4 ASCENT study of the Tudorza Pressair aclidinium bromide DPI in COPD patients showing significant reduction in exacerbations and hospitalizations to the inhaler’s label. Circassia announced in August 2018 that the FDA had accepted the sNDA for review.
Tudorza Pressair, which is known elsewhere as Eklira Genuair or Bretaris Genuair, was approved by the FDA in 2012 for the treatment of COPD. Circassia acquired US rights to the inhaler from AstraZeneca in 2017.
Circassia Chief Executive Steve Harris, commented, “This approval adds unique new clinical data to Tudorza’s label, which further differentiates this important COPD treatment option within the $2 billion US LAMA market. 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. Following our recent option exercise acquiring the full US commercial rights to Tudorza, and this subsequent label expansion, we look forward to implementing our strategy targeting product growth in this major market.”
Read the Circassia press release.
