May 1, 2015
By Riley McDermid and Alex Keown, BioSpace.com Breaking News Staff
The U.S. Food and Drug Administration (FDA) has followed its advisory panel’s recommendation, saying Thursday it has approved GlaxoSmithKline ’s drug Breo Ellipta to treat chronic breathing issues for adults with asthma, but not for adolescents. That news pushed Glaxo down slightly in Friday trading, because the regulator limited the conditions the drug can treat.
Glaxo said they were pleased at the decision, but noted the drug is not indicated for or the relief of acute bronchospasm. Analysts have estimated that sales of Breo Ellipta could reach $750 million by 2020.
“Asthma is a variable condition and guidelines recommend a stepwise approach to treatment with the aim of achieving asthma control,” said Darrell Baker, senior vice president and head of GSK Global Respiratory Franchise, in a statement. “Breo Ellipta is our second asthma treatment to be approved in the U.S. 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.”
The drug is a fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate (FF) and the long-acting beta2-agonist (LABA) vilanterol (VI).
On March 20, the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 16-4 that Breo Ellipta, which was licensed from Theravance, Inc. in 2002, should be approved for once daily treatment of asthma in adults 18 years and older. The panel voted 19-1 that the data did not support approval for use in children aged 12 to 17.
Breo Ellipta consists of a corticosteroid, which reduces inflammation, and vilanterol, a long-acting beta-agonist (LABA), which is designed to open the airways. The medication was approved by the FDA in May 2013 for use as a once-daily prescription medication for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Today’s approval marks the end of a long process: Glaxo initially filed a new drug application to use Breo Ellipta as an asthma treatment in June 2014.
“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 U.S.,” said Michael W. Aguiar, president and chief executive officer of Theravance, Inc., in a statement. “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.”
Because the LABA class of drugs has been linked with asthma-related deaths in the past, the FDA panel recommended that a large LABA safety trial should be required in adults and in youths 12 to 17 year of age, similar to ongoing LABA safety trials being conducted as an FDA Post-Marketing Requirement by each of the manufacturers of LABA containing asthma treatments, including GlaxoSmithKline‘s Advair, AstraZeneca PLC ‘s Symbicort and Merck & Co. ‘s Dulera and Foradil, in both adolescents and adults, GlaxoSmithKline said following the panel’s ruling. LABA drugs already come with warning labels noting the risks of taking such a medication.
Asthma, a chronic lung disease that inflames and narrows the airways, affects approximately 26 million people in the United States, including 7 million children, according to the National Institutes of Health (NIH).
