WASHINGTON (Reuters) - Reviewers for the U.S. Food and Drug Administration said on Monday that the efficacy data for GlaxoSmithKline Plc and Theravance Inc's experimental drug to treat chronic obstructive pulmonary disease are not entirely consistent.
The drug, Breo, is made up of 100 micrograms of a corticosteroid, fluticasone furoate (FF), and 25 micrograms of a long-acting beta-agonist, or LABA, called vilanterol (VI). The drug is administered via a new dry powder inhaler called Ellipta.
A clinical trial compared the efficacy and safety of once-daily Breo with that of vilanterol alone for the long-term maintenance treatment of airflow obstruction and the reduction of COPD exacerbations.
COPD refers to a group of lung diseases that block airflow and make breathing difficult. Emphysema, which is most frequently caused by smoking, and chronic bronchitis, an inflammation of the lining of the bronchial tubes, are the two most common conditions that make up COPD.
Reviewers said data in support of the benefit of Breo in improving lung function did not appear consistent, though the data did appear supportive for reducing COPD exacerbations. The reviewers said the drug's safety profile appears generally consistent with that of similar drugs.
The reviewer's opinions come ahead of a meeting of a panel of expert outside advisors to the FDA due to be held on Wednesday.
(Reporting By Toni Clarke in Washington; Editing by Maureen Bavdek)
Source: http://news.yahoo.com/fda-reviewers-data-glaxos-breo-not-consistent-124021026--finance.html
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