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AstraZeneca gets first European approval for Pulmicort inhaler

Date published: 10/02/2006

AstraZeneca has received its first regulatory approval for a new pressurised metered-dose inhaler (pMDI) for the asthma treatment Pulmicort (budesonide). The inhaler, developed by SkyePharma, received clearance in Finland and further approvals in EU and non-EU markets are being awaited.

The pMDI is to replace current chlorofluorocarbon (CFC) inhalers that have been on the market since 1981. Dr Dave Singh, senior lecturer at South Manchester University Hospitals Trust said: "As one of the principal investigators in the extensive clinical programme, I am happy to conclude that the new HFA based formulation has comparable clinical effects to the current CFC formulation, thus allowing clinicians to make a seamless transition to the new formulation.

"This new Pulmicort HFA pMDI secures continuous use of one of the best documented inhaled steroids and thus provides an important treatment for many asthma patients." The new inhaler has become necessary under the Montreal Protocol that aims to stop the use of CFCs that affect the ozone layer.

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