FDA approved the first generic of fluticasone propionate and salmeterol inhalation powder (Advair Diskus, GlaxoSmithKline) to treat asthma and chronic obstructive pulmonary disease (COPD).
The Wixela Inhub inhaler (Mylan), which will launch later this month, is indicated for the twice daily treatment of asthma in patients aged 4 years and older not adequately controlled on long-term asthma control medications or whose disease warrants initiation of treatment with both inhaled corticosteroids and long-acting beta agonists, maintenance treatment of COPD, and the reduction of COPD exacerbations in patients with a history of exacerbations, Mylan said in a statement.
FDA’s approval of Wixela Inhut represents a potentially significant windfall for Mylan, since Advair Diskus boasted US sales of $4.2 billion for the 12 months ending November 30, 2018, according to IQVIA.
Wixela Inhub will be available in the 100 µg/50 µg, 250 µg/50 µg and 500 µg/50 mcg strengths for asthma patients and the 250 µg /50 µg strength for COPD patients.
Mylan sought FDA’s approval of the generic version of Advair Diskus for years, and invested more than $700 million in research and development of the medication, said Mylan CEO Heather Bresch in the company’s statement.
“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,” added Rajiv Malik, president of Mylan. “This complex product required a rigorous research and development program spanning over a decade and close collaboration with FDA to define the regulatory pathway.”
FDA’s approval of the “first generic drug product for one of the most commonly prescribed asthma and COPD inhalers in the US is part of our longstanding commitment to advance access to lower cost, high quality generic alternatives,” said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, in a statement from the agency. “People living with asthma and COPD know too well the critical importance of having access to the treatment they need to feel better. Today’s approval will bring more competition to the market which will ultimately benefit the patients who rely on this drug.”
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