GlaxoSmithKline's shares rose Thursday after the healthcare company announced US approval of Breo Ellipta, a treatment for chronic obstructive pulmonary disease (COPD).
Breo Ellipta, once-daily inhaled treatment for the long-term, maintenance treatment of airflow obstruction in patients with COPD, was given the green light from the Food and Drug Administration's (FDA) Pulmonary-Allergy Drugs Advisory Committee.
The committee voted that the efficacy and safety data provide substantial evidence to support approval of the medication. The company submitted a new drug application to the FDA for approval of Breo last July.
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"We are pleased with the outcome of today's meeting," said President of GlaxoSmithKline Pharmaceuticals, Patrick Vallance.
"COPD is a debilitating and progressive disease. Its symptoms are often severe and can have a huge impact on patients' lives. This positive recommendation is a crucial first step towards making Breo Ellipta available for appropriate COPD patients across the US.
"We look forward to a final decision from the FDA later this year."
RD
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