The US Food and Drug Administration (FDA) has approved Mylan’s generic version of GlaxoSmithKline’s (GSK) asthma treatment Advair Diskus (fluticasone propionate and salmeterol inhalation powder).
Dubbed Wixela Inhub, Mylan’s treatment is the first generic of Advair. The FDA approved three dosages of the generic inhaler for twice-daily asthma therapy in patients aged four years and older.
It can also be used for the maintenance treatment of airflow obstruction and decreasing exacerbations in chronic obstructive pulmonary disease (COPD) patients.
Mylan evaluated various strengths of Wixela Inhub in a research and development programme.
The bioequivalence of the generic’s 100mcg/50mcg dosage was compared to that of Advair Diskus in a 28-day randomised, double-blind, placebo-controlled, parallel clinical trial involving 1,128 adult asthma patients.
Data showed equivalent efficacy of the treatments, with both of them being safe and well-tolerated.
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Mylan CEO Heather Bresch said: “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 research and development program and Mylan’s more than $700m of investment.”
The FDA agreed to review Mylan’s abbreviated new drug application (ANDA) for the generic in March 2017.
The FDA decision increased Mylan’s shares by 7% on 30 January 2019, reported Reuters. The news agency added that the US regulatory authority previously declined Advair generics by various companies such as Novartis and Hikma Pharmaceuticals.
According to statistics from IQVIA, Advair Diskus generated about $4.2bn in US sales in the 12 months ending 30 November 2018.
FDA Center for Drug Evaluation and Research director Janet Woodcock said: “Today’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.
“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.”
Mylan currently offers more than 1,400 generic and branded pharmaceuticals across nearly 165 countries and territories. Its respiratory portfolio consists of more than 700 products.