Portfolio company Circassia, a world-class specialty biopharmaceutical business focused on allergy and asthma, has announced the positive outcome of the European Decentralised Procedure (DCP) for the Company’s fluticasone propionate pressurised metered dose inhaler (pMDI) generic equivalent of GlaxoSmithKline’s FLIXOTIDE® pMDI for the prophylactic treatment of asthma.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will issue a national marketing licence. The product will be submitted under the Mutual Recognition Procedure for approval in other EU Member States.
Steve Harris, Circassia’s Chief Executive, said:
“Achieving this positive outcome is a major milestone for Circassia, marking the favourable 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.”