LONDON (Alliance News) - Circassia Pharmaceuticals PLC on Tuesday said its fluticasone propionate pressurised metered dose inhaler (pMDI) generic equivalent of GlaxoSmithKline's FLIXOTIDE pMDI for the prophylactic treatment of asthma has received a stamp of approval from the UK's Medicines and Healthcare Products Regulatory Agency.
Approval means that the issue of a national licence will now begin.
"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," Chief Executive Steve Harris said in a statement.
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," Harris said.
"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," Harris added.
The product is being developed in collaboration with Mylan NV.
Circassia shares were up 3.3% to 273.6 pence early Tuesday, one of the best performers in the FTSE 250.
By Samuel Agini; samagini@alliancenews.com; @samuelagini
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