GSK sees FDA clearance for asthma drug
pharmafile | May 1, 2015 | News story | Sales and Marketing | Breo Ellipta, FDA, GSK, Theravance
GlaxoSmithKline and Theravance’s Breo Ellipta inhaler has been approved by the FDA to treat asthma in adults.
Whilst the once-daily treatment has been given the nod for patients aged 18 and older, both firms will be disappointed that the US regulator declined to approve Breo (fluticasone furoate/vilanterol) for younger asthma sufferers.
The agency has told the firms that additional data will be required to further demonstrate Breo’s safety and efficacy in that population.
Darrell Baker who is head of GSK’s respiratory franchise, says: “Asthma is a variable condition and guidelines recommend a stepwise approach to treatment with the aim of achieving asthma control.
“Breo Ellipta is our second asthma treatment to be approved in the US in the past year, and now provides physicians with a range of treatment options delivered via the Ellipta inhaler to meet the needs of appropriate adult patients with differing asthma severities.”
GSK licensed the drug from Theravance back in 2002, now its efficacy and safety have been studied in the latest clinical trial that involved over 12,000 subjects in 23 studies of patients aged 12 and over.
Breo was licensed by the FDA in May 2013 as a prescription medication for the once-daily, maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
GSK has been through a tough time with its respiratory sales recently, so will be pinging its hopes on Breo to help make up for any decline in sales of its top-selling drug Advair (fluticasone/salmeterol) – which is due to lose its patent protection as soon as next year.
The drug’s co-owner is clearly positive about its outcome, with Michael Aguiar the president and chief executive of Theravance commenting: “We believe the approval of Breo Ellipta as a once-daily ICS/LABA treatment for adults with asthma is a significant catalyst for Theravance, as asthma affects nearly 19 million adults in the US.
“We are pleased by today’s approval of Breo Ellipta and look forward to making this important medicine available to the appropriate adult patients among those living with the disease.”
Brett Wells
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