FDA
approves Glaxo, Theravance's Breo Ellipta asthma drug
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[May 01, 2015]
(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.
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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.
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.
Breo Ellipta should not be used for the relief of acute bronchospasm,
the companies said.
Bernstein analyst Tim Anderson had forecast Breo sales reaching $750
million in 2020.
The drug consists of a corticosteroid, which reduces inflammation,
and a long-acting beta-agonist called vilanterol, which is designed
to open the airways.
Glaxo licensed the drug from Theravance in 2002.
The inhaled treatment was previously approved to treat chronic
obstructive pulmonary disease, or COPD, a condition that includes
emphysema, chronic bronchitis or both.
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(Reporting by Bill Berkrot in New York; Editing by Leslie Adler)
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