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Steering the Design, Manufacture and Control of Genuair/Pressair Through Regulatory Approval

Niederlaender C, Mahashabde S.

RDD Europe 2013. Volume 1, 2013: 131-140.

Abstract:

Genuair/Pressair is a novel, multidose, breath actuated dry powder inhaler approved in 2012 by EMA and FDA for the delivery of aclidinium bromide, a novel long acting muscarinic antagonist (LAMA). The product is presently marketed as Eklira Genuair and Bretaris Genuair in Europe and as Tudorza Pressair in the USA. Further approvals and late stage clinical trials are ongoing in Japan and South Korea. Genuair/Pressair inhaler development was based on the Novolizer, a reservoir dry powder inhaler (DPI) that is approved and established in Europe. During development, the dry powder dispersion system from Novolizer was modified – different plastic materials were utilized and the internal design optimized such that product performance satisfied worldwide regulatory requirements. This article describes the global development of Genuair/Pressair, including the hurdles that were encountered due to differences in the regulatory requirements between Europe and the US.