FDA Staff Says GSK Is Missing Data On Pulmonary Drug

Law360, Washington (September 6, 2013, 1:32 PM EDT) -- U.S. Food and Drug Administration staff on Friday cautioned an agency advisory committee against relying heavily on safety and efficacy data for GlaxoSmithKline PLC and Theravance Inc.'s proposed chronic obstructive pulmonary disease treatment, saying missing data may affect the overall results.

Although the company presented multiple studies to the FDA showing the once-daily inhaled treatment, called Anoro Ellipta, is effective against COPD, staffers claimed the data might not be reliable because patients weren't checked on post-treatment for a complete safety evaluation. The concerns were brought up...
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