Prosonix's marketing application for generic of Flixotide under EU review

Prosonix’s marketing authorization application of its generic pressurized metered-dose inhaler containing fluticasone propionate is being assessed by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom, according to a press release.

Prosonix submitted the marketing authorization application (MAA) under the Decentralised Procedure with a duplicate MAA on behalf of Mylan for PSX1001. The drug is a generic version of GlaxoSmithKline’s pressurized metered-dose inhaler Flixotide, indicated for treating asthma, according to the release.

The submission leverages the EU regulatory guideline that “potentially allows the approval of generic inhaled products on the basis of in vitro-only demonstration of therapeutic equivalence of the candidate to the reference product,” the release said.

“The achievement of this key milestone is a landmark event for Prosonix,” David Hipkiss, CEO and co-founder of Prosonix, said in the release. “Our MAA for PSX1001 is the first of our product pipeline to be reviewed under the EU regulatory guidelines that allow the potential approval of generic inhaled products based on in vitro data alone.

“We are excited to be able to use this regulatory approach to deliver our strategy, consistent with the new Global Initiative for Asthma management and prescribing guidelines which we believe are set to dominate the reimbursement and payer agenda for the foreseeable future.”

Under the licensing agreement, Prosonix is responsible for filing PSX1001 in the European Union and marketing rights in certain territories. Mylan has marketing rights for PSX1001 and PSX1050 (the generic equivalent of GSK’s Flovent) in the US, Canada, Australia, New Zealand, India, Japan, the EU and other countries, according to the release. The MAA assessment resulted in an undisclosed payment from Mylan, the release said.