The FDA announced Wednesday that it cleared Mylan's Wixela, making it the first generic version of GlaxoSmithKline's Advair Diskus (fluticasone/salmeterol) inhaler approved in the US. Mylan's product is indicated for the twice-daily treatment of asthma in patients aged four years and older, as well as maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease. Shares in Mylan gained as much as nearly 7 percent on the news.
Analysts at Leerink said they expect Mylan to launch Wixela in February and generate 2019 sales of about $170 million from the therapy. Meanwhile, Citi analyst Liav Abraham underscored the importance of the FDA approval for Mylan, even though the potential revenue opportunity from a generic version of Advair has fallen over the past several years.
GlaxoSmithKline, which amassed about $4.1 billion in sales for Advair in 2017, has been preparing for the potential approval of a generic Advair inhaler for several quarters. In the third quarter of 2018, the company reported that respiratory product sales had grown 3 percent despite a 17-percent decline in revenue from Advair.
The FDA initially accepted Mylan's filing for generic Advair in 2016, and later issued a complete response letter, although the company did not specify the reason for the rejection. Last year, Mylan said it expected to receive a complete response letter at the end of June for its resubmission after the FDA told the company it had identified "minor deficiencies." In October, following "multiple inquires" over the status of its Wixela application, Mylan issued a statement saying it had "not received any new information request or complete response letter from the FDA," and believed that approval was "imminent."
In 2017, FDA Commissioner Scott Gottlieb unveiled several initiatives seeking to speed the approval of complex generics. Following Wednesday's approval, Anna Abram, deputy commissioner for policy, planning, legislation and analysis at the agency, commented "we are committed to advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we're prioritising review of many applications covering proposed generic complex products for which a generic has not yet been approved."
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