Flixotide® / Flovent® substitute
Circassia’s product is a particle-engineered version of fluticasone propionate, an inhaled corticosteroid used in the treatment of asthma. It is delivered via pressurized metered dose inhaler (pMDI), and is designed to be a substitute for GSK’s Flixotide® / Flovent® pMDI. It was previously approved in the UK under the EU’s decentralized procedure.
The product is out-licensed in key territories1 and Circassia retains rights in certain territories, including Japan, China, South America, the Middle East and Africa.
The product’s marketing authorization application was previously approved by the UK’s Medicines and Healthcare Products Regulatory Agency under the EU’s decentralized procedure. The filing exploited the EU regulatory guidelines that allow for the approval of substitute inhaled products based on in vitro equivalence data only, without the need for clinical studies. In the US, the FDA guidelines allow for pharmacokinetic and clinical endpoint or pharmacodynamic studies rather than lengthy clinical programs.
1 US, Canada, Australia, New Zealand, India, the EU, Iceland, Liechtenstein, Norway, Switzerland, Turkey, Russian Federation and the Commonwealth of Independent States