Mylan’s treatment is the first generic of asthma treatment Advair Diskus. Credit: David Camerer.

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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.

“Today’s approval will bring more competition to the market which will ultimately benefit the patients who rely on this drug.”

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.