U.S approval of GlaxoSmithKline’s newest respiratory inhaler continues the global drugmaker’s shift from the blockbuster drug Advair to a suite of drugs that will be assembled at the British company’s Zebulon manufacturing site.
GSK said Thursday the company and business partner Theravance won approval from the Food and Drug Administration to market Breo Ellipta for asthma. The drug had been approved in 2013 for chronic obstructive pulmonary disease, but it failed to win approval for sale to minors as GSK officials had hoped.
Breo Ellipta is the fourth drug in the Ellipta platform approved in the past year and a half. The company has five more in the pipeline, including an injectable asthma treatment awaiting a ruling from the FDA.
GSK plans to start production of Breo Ellipta this year in Zebulon, said spokesman Juan Carlos Molina.
“Our respiratory business has evolved from a singular focus on one brand to a portfolio approach of four respiratory medicines,” Molina said.
Advair, GSK’s best-seller and one of the world’s top-selling medications, has been in a sales decline and its patent protection is set to expire in 2016, clearing the way for generics. Advair accounted for nearly a fifth of GSK’s revenue in 2014, racking up $7 billion in sales, but last year’s sales were down 27 percent from 2013.
Declines in sales and sweeping changes in the pharmaceutical industry have prompted a corporate reorganization at GSK that will cost more than 1,000 jobs in North Carolina. The company is in the midst of its reorganization and couldn’t say how many people it employs at its North American headquarters in Research Triangle Park.
Until recently GSK’s RTP site had 5,000 employees, but it’s eliminating jobs at the same time that it is absorbing employees from a Novartis vaccines unit it acquired.
GSK’s Zebulon facility company makes and packages more than 20 medications, including Advair and Flovent. The site has 450 employees and 150 contractors.
GSK, like many other drug makers, is seeking approvals for new ways of delivering drugs. Advair, for example, lost its patent protection in 2010 but is still patented for its Diskus apparatus.
The new Ellipta suite stores constitutent medications in separate chambers, not in a mixed formulation. The inhaler releases up to three separate medications simultaneously to blend when the patient takes a “puff.”
Breo Ellipta is a once-a-day inhaler that GSK had hoped to market to adults as well as children aged 12 to 17, but GSK said the company failed to make its case for sale to minors.