<span id="midArticle_start"/> April 30 (Reuters) - The U.S. Food and Drug Administration on Thursday approved the sale of Breo Ellipta as a once-daily treatment for asthma in patients aged 18 and older, GlaxoSmithKline and Theravance Inc said.
<span id="midArticle_0"/>The FDA declined to approve Breo for younger asthma sufferers. The agency, in a so-called complete response letter, told the companies that additional data would be required to further demonstrate Breo's safety and efficacy in that population.
<span id="midArticle_1"/>The FDA's decision came after an FDA advisory panel of experts had voted 16-4 that Breo Ellipta should be approved for use by adults. It voted 19-1 that available data did not support approval for use in children aged 12 to 17.
<span id="midArticle_2"/>Breo Ellipta should not be used for the relief of acute bronchospasm, the companies said.
<span id="midArticle_3"/>Bernstein analyst Tim Anderson had forecast Breo sales reaching $750 million in 2020.
<span id="midArticle_4"/>The drug consists of a corticosteroid, which reduces inflammation, and a long-acting beta-agonist called vilanterol, which is designed to open the airways.
<span id="midArticle_5"/>Glaxo licensed the drug from Theravance in 2002.
<span id="midArticle_6"/>The inhaled treatment was previously approved to treat chronic obstructive pulmonary disease, or COPD, a condition that includes emphysema, chronic bronchitis or both. (Reporting by Bill Berkrot in New York; Editing by Leslie Adler)
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<span id="midArticle_0"/>The FDA declined to approve Breo for younger asthma sufferers. The agency, in a so-called complete response letter, told the companies that additional data would be required to further demonstrate Breo's safety and efficacy in that population.
<span id="midArticle_1"/>The FDA's decision came after an FDA advisory panel of experts had voted 16-4 that Breo Ellipta should be approved for use by adults. It voted 19-1 that available data did not support approval for use in children aged 12 to 17.
<span id="midArticle_2"/>Breo Ellipta should not be used for the relief of acute bronchospasm, the companies said.
<span id="midArticle_3"/>Bernstein analyst Tim Anderson had forecast Breo sales reaching $750 million in 2020.
<span id="midArticle_4"/>The drug consists of a corticosteroid, which reduces inflammation, and a long-acting beta-agonist called vilanterol, which is designed to open the airways.
<span id="midArticle_5"/>Glaxo licensed the drug from Theravance in 2002.
<span id="midArticle_6"/>The inhaled treatment was previously approved to treat chronic obstructive pulmonary disease, or COPD, a condition that includes emphysema, chronic bronchitis or both. (Reporting by Bill Berkrot in New York; Editing by Leslie Adler)
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