STAT+: CEO of GSK plays down its role in FDA effort to approve therapy for autism-related condition

STAT+: CEO of GSK plays down its role in FDA effort to approve therapy for autism-related condition










BOSTON — The CEO of the drugmaker GSK on Wednesday said the company has had a minimal role in the Food and Drug Administration’s effort to update the prescribing information of a long-shelved drug so that it can be used to treat a condition often associated with autism.

The FDA’s request that the company update the prescribing information for its decades-old therapy leucovorin is “an administrative request,” the CEO, Emma Walmsley, said during a panel discussion at the STAT Summit.

“We have no commercial interest, we have no scientific research, and we’re not pursuing it,” she added. “So it’s just the administration at this stage.”

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Elaine Chen





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