<span id="midArticle_start"/>April 30 (Reuters) - The U.S. Food and Drug Administrationon Thursday approved the sale of Breo Ellipta as a once-dailytreatment 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 asthmasufferers. The agency, in a so-called complete response letter,told the companies that additional data would be required tofurther demonstrate Breo's safety and efficacy in thatpopulation.
<span id="midArticle_1"/>The FDA's decision came after an FDA advisory panel ofexperts had voted 16-4 that Breo Ellipta should be approved foruse by adults. It voted 19-1 that available data did not supportapproval for use in children aged 12 to 17.
<span id="midArticle_2"/>Breo Ellipta should not be used for the relief of acutebronchospasm, the companies said.
<span id="midArticle_3"/>Bernstein analyst Tim Anderson had forecast Breo salesreaching $750 million in 2020.
<span id="midArticle_4"/>The drug consists of a corticosteroid, which reducesinflammation, 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 treatchronic obstructive pulmonary disease, or COPD, a condition thatincludes emphysema, chronic bronchitis or both. (Reporting by Bill Berkrot in New York; Editing by LeslieAdler)
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<span id="midArticle_0"/>The FDA declined to approve Breo for younger asthmasufferers. The agency, in a so-called complete response letter,told the companies that additional data would be required tofurther demonstrate Breo's safety and efficacy in thatpopulation.
<span id="midArticle_1"/>The FDA's decision came after an FDA advisory panel ofexperts had voted 16-4 that Breo Ellipta should be approved foruse by adults. It voted 19-1 that available data did not supportapproval for use in children aged 12 to 17.
<span id="midArticle_2"/>Breo Ellipta should not be used for the relief of acutebronchospasm, the companies said.
<span id="midArticle_3"/>Bernstein analyst Tim Anderson had forecast Breo salesreaching $750 million in 2020.
<span id="midArticle_4"/>The drug consists of a corticosteroid, which reducesinflammation, 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 treatchronic obstructive pulmonary disease, or COPD, a condition thatincludes emphysema, chronic bronchitis or both. (Reporting by Bill Berkrot in New York; Editing by LeslieAdler)
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