FDA approved the first generic version of GSK’s Advair Diskus

The FDA has approved the first generic version of GSK’s Advair Diskus, a fluticasone propionate and salmeterol inhalation powder product in January of this year. The generic drug known as Wixela Inhub developed by Mylan is indicated to treat patients with asthma and chronic obstructive pulmonary disease (COPD), including bronchitis and emphysema. Wixela Inhub is expected to available in the market from late February. The generic product will be available in the 250 mcg/50 mcg strength for COPD and for asthma the drug is available at 100 mcg/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg strengths. The newly approved inhalation powder contains a corticosteroid and a long-acting beta (2)-adrenergic agonist (LABA) indicated for twice-daily for maintenance of airflow obstruction and reducing exacerbations in patients with COPD and also for asthma patients aged 4 years and older. There was no generic approved product by FDA for this complex drug-device combination.

FDA approved

After the approval, Mylan President Rajiv Malik said, “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 research and development 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.”

Chronic obstructive pulmonary disease (COPD) is the 5th leading cause of death with 3.15 million deaths globally, according to the WHO predictions that it will become the third leading cause of death worldwide by 2030. COPD is affecting 251 million lives globally. More than 90% COPD-related deaths happen in low and middle-income countries. In the US alone, 26 million people have asthma and 16 million people are living with COPD. According to FDA, this approval should provide greater patient access to this medication.

– Arpitha Shetty
Research Analyst,
Infoholic Research