The FDA has approved Duaklir Pressair aclidinium bromide/formoterol fumarate DPI for the treatment of COPD, Circassia Pharmaceuticals has announced. Circassia said in August 2018 that the FDA had accepted the NDA for Duaklir and an sNDA for Tudorza Pressair aclidinium bromide DPI, which has also been approved. The company says that it plans to launch Duaklir in the US during the second half of 2019.
Circassia licensed rights to Duaklir and Tudorza from AstraZeneca in 2017. The company says that approval of Duaklir requires payment of a $29 million contingent option fee to AstraZeneca within 30 days in addition to $100 million that had been deferred, which is due by June 30, 2019. According to Circassia, it “is in discussions with third-party finance providers to satisfy all or part of these payments.” If that financing falls through, AstraZeneca will provide a loan facility under the agreement.
Circassia CEO Steve Harris commented, “We are delighted with the FDA approval of Duaklir, which we believe will provide a valuable treatment option for the significant number of patients with COPD in the United States. The addition of Duaklir to our portfolio further strengthens our range of marketed respiratory products and we look forward to launching it in the US in the coming months alongside our aclidinium monotherapy, Tudorza, as part of the significant LAMA / LABA market that is predicted to grow rapidly over the coming years.”
Circassia VP, US Medical Affairs, Michael Asmus, added, “With guidelines recommending combined LAMA and LABA therapy for a number of COPD patient groups, we believe Duaklir will make an important contribution to the treatment of this debilitating disease. Dukalir’s approval is based on a broad clinical database, including data demonstrating a reduction in the risk of COPD exacerbations driven by its aclidinium component, and we look forward to making this new therapeutic option available to patients across the United States.”
Read the Circassia press release.
