Flixotide® / Flovent® substitute

Circassia’s product is a particle-engineered version of fluticasone propionate, a potent 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 recently approved under the brand name Fliveo® in the UK and Sweden under the EU’s decentralized procedure.

Product progress

Under previous ownership the product was out-licensed in key territories1 and Circassia has now initiated negotiations for the return of the rights in the EU. Circassia also retains rights in certain territories, including Japan, China, South America, the Middle East and Africa.

The product’s marketing authorization application was recently approved by the UK’s Medicines and Healthcare Products Regulatory Agency under the EU’s decentralized procedure.  The filing exploits 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

Pipeline status: Flixotide® substitute

ResearchPre-clinicalPhase IPhase IIPhase III /
Registration Study /
Substitute
Filed /
Approved

Pipeline status: Flovent® substitute

ResearchPre-clinicalPhase IPhase IIPhase III /
Registration Study /
Substitute
Filed /
Approved

View Circassia's full pipeline chart