FDA Approves Generic Inhalation Treatment for Asthma, COPD

The FDA has approved the first generic version of Advair Diskus (GlaxoSmithKline), a fluticasone propionate and salmeterol inhalation powder product.

The generic drug (Wixela Inhub, Mylan) is indicated to treat patients with asthma and chronic obstructive pulmonary disease (COPD), including bronchitis and emphysema.¹

Wixela Inhub is expected to launch in late February, according to Mylan.

The generic product will be available in the 100 mcg/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg strengths for treating asthma, and the 250 mcg/50 mcg strength for COPD.²

The newly approved fluticasone propionate and salmeterol inhalation powder contains a corticosteroid and a long-acting beta(2)-adrenergic agonist (LABA) indicated for twice-daily treatment of asthma in patients aged 4 years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with COPD. This medicine is a complex drug-device combination product for which no generic product has been previously approved by FDA.¹

Generic drugs are approved once they have met the FDA’s rigorous approval standards to ensure that the generic drug is as effective and safe as the brand name drug product. The generic must also meet the same quality requirements for manufacturing and packaging as the brand name drug product. The FDA expedited the review of this abbreviated new drug application (ANDA) as a potential first generic.¹

"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 research and development program spanning over a decade and close collaboration with FDA to define the regulatory pathway," Mylan President Rajiv Malik said in a statement.²

"We also are proud to manufacture Wixela Inhub in our own state-of-the-art plant," Malik said. "This approval reinforces our ongoing commitment to increase access to more affordable treatment options for patients."

In the 28-day, double-blind, parallel, placebo-controlled, and randomized group study of 1128 adult asthma patients conducted to evaluate the local (lung) bioequivalence of Advair Diskus 100 mcg/50 mcg and Wixela Inhub 100 mcg/50 mcg, the 2 treatments produced equivalent efficacy.

Both treatments were safe and well-tolerated with lower numbers of withdrawals, because of asthma compared with the placebo group, according to Mylan.

The study included both current and naive users of Advair Diskus.²

"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," said Edward Kerwin, MD of Crisor LLC, a division of the Clinical Research Institute in Medford, Oregon, and a clinical investigator on the Wixela Inhub clinical program.²

"We have waited for years for generic inhalers to emerge in respiratory medicine," he said.

In the United States, 26 million people, including children, have asthma and 16 million people are living with COPD.

This approval should provide greater patient access to this medication, according to the FDA.¹

This article was updated on January 31, 2019.

Reference

• FDA approves first generic Advair Diskus [news release]. Silver Spring, MD; January 30, 2019: FDA website. http://www.pharmacytimes.com/link/251. Accessed January 30, 2019.
• Mylan Announces FDA approval of Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), first generic of ADVAIR DISKUS (fluticasone propionate and salmeterol inhalation powder) [news release]. Hertfordshire, UK, and Pittsburgh, PA; January 31, 2019: Mylan website. investor.mylan.com/news-releases/news-release-details/mylan-announces-fda-approval-wixelatm-inhubtm-fluticasone. Accessed January 31, 2019.