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Fluticasone propionate/salmeterol (Wixela® Inhub®) dry-powder inhaler in asthma and COPD: a profile of its use in the USA

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Abstract

Wixela® Inhub® is the first therapeutically equivalent, substitutable generic version of Advair Diskus® (fluticasone propionate/salmeterol) approved for the treatment of asthma and chronic obstructive pulmonary disease (COPD) in the USA. Wixela Inhub combines the inhaled corticosteroid fluticasone propionate and the long-acting β2-adrenoceptor agonist salmeterol in a single dry-powder inhaler. Each drug has a different mechanism of action, targeting different and complementary aspects of the pathophysiology of asthma and COPD. The in vitro performance of Wixela Inhub is comparable to that of Advair Diskus at all dosage strengths (100/50 μg, 250/50 μg, and 500/50 μg) and all flow rates. Wixela Inhub has pharmacokinetic and pulmonary therapeutic bioequivalence to Advair Diskus, which has well-established efficacy, tolerability, and safety profiles. The Wixela Inhub device is robust and easy to use without instruction. All three dosage strengths of Wixela Inhub will be offered at a wholesale acquisition cost of up to 70% less than Advair Diskus and the authorized generic equivalent.

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Acknowledgements

The manuscript was reviewed by: T. E. Albertson, Department of Internal Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, University of California, Davis, Sacramento, CA, USA and VA Northern California Health Care System, Mather, CA, USA; E. M. Kerwin, Clinical Research Institute of Southern Oregon, Medford, OR, USA; J. F. M. van Boven, University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD (GRIAC), Department of Clinical Pharmacy & Pharmacology, Groningen, Netherlands. During the peer review process, Mylan, the marketing-authorization holder of Wixela® Inhub®, was offered an opportunity to provide a scientific accuracy review of their data. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Hannah A. Blair

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  1. Hannah A. Blair
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Correspondence to Hannah A. Blair.

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The preparation of this review was not supported by any external funding.

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H. A. Blair is an employee of Adis International Ltd./Springer Nature, is responsible for the article content and declares no conflicts of interest.

Additional information

Enhanced material for this Adis Drug Q&A can be found at https://doi.org/10.6084/m9.figshare.9899648.

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Blair, H.A. Fluticasone propionate/salmeterol (Wixela® Inhub®) dry-powder inhaler in asthma and COPD: a profile of its use in the USA. Drugs Ther Perspect 35, 583–591 (2019). https://doi.org/10.1007/s40267-019-00686-w

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