FDA Panel Votes Against Approval of GSK Lung Disease Drug

By Reuters Staff

WASHINGTON (Reuters) - A U.S. Food and Drug Administration expert panel on Wednesday did not support approval of GlaxoSmithKline Plc's drug Nucala for treating chronic obstructive pulmonary disease.

The panel found that the drug, which is already approved for treating severe asthma, was safe but that it did not demonstrate efficacy for a new indication. FDA staff reviewers earlier raised doubts as to whether the data GSK submitted provided evidence of the drug's efficacy.

GSK said it would work with the agency to address its concerns.

While the FDA is not obliged to follow the advice of its experts, it generally does.

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