According to Circassia Pharmaceuticals, the UK has approved the company’s generic fluticasone propionate MDI for the treatment of asthma under the European decentralized procedure. The MAA includes the same three strengths (50µg, 125µg and 250µg per actuation) as GSK’s Flixotide fluticasone propionate MDI, and the company will now submit marketing applications in other EU member states under the mutual recognition procedure for approval of the MDI as a direct substitute.
Circassia said that the fluticasone MDI was approved on the basis of in vitro equivalence data alone under the European regulatory guideline CPMP/EWP/4151/00 Rev. 1, which it believes is a first for a product with multiple product strengths. The company acquired the product, which is licensed to Mylan, when it acquired inhaled drug developer and particle engineering specialist Prosonix in June 2015.
Circassia Chief Executive Steve Harris said, “Achieving this positive outcome is a major milestone for Circassia, marking the favorable conclusion of the company’s first ever Marketing Authorisation Application for a product using its particle-engineering technology. This achievement is also highly significant as it is the first time a marketing application has successfully used in vitro data only to demonstrate therapeutic equivalence for a respiratory product across a range of strengths, avoiding the need for clinical studies. This positive outcome provides unequivocal validation of Circassia’s novel particle-engineering technology, and as a result we look forward to filing our next respiratory product in 2016.”
Read the Circassia press release.
