FDA approves first generic Advair Diskus

Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP)

Mylan's Wixela Inhub is the first FDA-approved therapeutically equivalent generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for certain patients with asthma or COPD.

Wixela Inhub will launch in the second half of February incorporating the latest safety information required by FDA last month, which prompted an amendment to the label for certain inhaled corticosteroids, including Advair Diskus and any generic versions. Wixela Inhub will be available in the 100 mcg/50 mcg, 250 mcg/50 mcg and 500 mcg/50 mcg strengths for asthma patients and the 250 mcg/50 mcg strength for COPD patients.

Mylan CEO Heather Bresch commented: "Mylan remains steadfast in its efforts to expand patient access to medicines, and the FDA approval of Wixela Inhub reinforces our commitment to provide patients greater choice and lower-cost alternatives. This milestone represents the culmination of an extensive R&D program and Mylan's more than $700 million of investment. We're proud of our Wixela Inhub team, who worked tirelessly and in close collaboration with the FDA to bring this important medicine to market and add it to our growing global portfolio of more than 700 respiratory products. As one of the leading providers of prescription medicines in the US, we continue to execute on our mission and do our part to reduce costs for patients and identify pathways that help increase sustainability for the US healthcare system overall."

Mylan President Rajiv Malik added: "We're pleased to offer the first FDA-approved generic of Advair Diskus, one of the leading treatments for asthma and COPD management today. We've long been confident in the science around this product and are proud of the dedication of our scientific teams to bring Wixela Inhub to market. This complex product required a rigorous R&D program spanning over a decade and close collaboration with FDA to define the regulatory pathway. We also are proud to manufacture Wixela Inhub in our own state-of-the-art plant. This approval reinforces our ongoing commitment to increase access to more affordable treatment options for patients."

"Patients enrolled in clinical trials found Wixela Inhub easy-to-use and highly effective at controlling their asthma in a clinical bioequivalence study. Asthma and respiratory specialists and primary care providers welcome this generic alternative to benefit many patients with asthma and COPD. We have waited for years for generic inhalers to emerge in respiratory medicine," said Edward Kerwin, MD of Crisor, a division of the Clinical Research Institute located in Medford, Ore. and a Clinical Investigator on the Wixela Inhub clinical program.

Advair Diskus had US sales of $4.2 billion for the 12 months ending 30 November 2018, according to IQVIA.