Shares of GlaxoSmithKline took a slight dip Wednesday afternoon after the U.S. Food and Drug Administration approved Mylan NV’s generic version of Advair Diskus, a staple blockbuster drug in the U.K. pharmaceutical company’s pipeline.
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Shares of GlaxoSmithKline took a slight dip Wednesday afternoon after the U.S. Food and Drug Administration (FDA) approved Mylan’s generic version of Advair Diskus, a staple blockbuster drug in the U.K. pharmaceutical company’s pipeline.
The FDA’s approval marks the first generic for Advair (fluticasone propionate and salmeterol inhalation powder) in the United States. The FDA approved Advair for the twice-daily treatment of asthma in patients aged four years and older, as well as a maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). The FDA approved Mylan’s Advair generic in three doses, 100/50, 250/50 and 500/50. Last year the FDA rejected its Advair generic due to “minor deficiencies.” What those were, have not been disclosed. Last year, the FDA also rejected an Advair generic developed by Novartis.
In 2017, Advair generated more than $4 billion for GlaxoSmithKline, about half of the $9 billion the company earns on respiratory products. Citing analysts at Leerink, Reuters said Mylan will likely launch its generic of Advair in February and snag about $170 million in revenue this year. While Advair has been a strong driver for GSK, the company has moved patients to other respiratory treatments, such as BREO, in anticipation of potential generic challenges to Advair. While Mylan’s generic is not likely to bring in billions of dollars annually, it will still be an important part of the company’s pipeline.
In the United States, more than 26 million people are known to have asthma, about seven million of these people are children, according to the FDA.
Following the FDA approval, shares of Mylan jumped more than 7 percent to close at 30.82.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said Mylan’s generic is the first for one of the most commonly prescribed inhalers for asthma and COPD. The approval of the generic drug is part of the FDA’s commitment to advancing generic alternatives to high-cost branded drugs. Woodcock said the generic approval will provide more competition to the market and will “ultimately benefit the patients who rely on this drug.”
Since the start of 2019, the FDA has approved seven generic drugs. The first five were approved on Jan. 3, with the most recent, Teva Pharmaceutical’s generic of Lundbeck’s Sabril, a treatment for refractory complex partial seizures in patients 10 years of age and older who have responded inadequately to several alternative treatments. In January 2018, the FDA approved five generic drugs.
