GSK's Role in FDA Effort to Approve Autism-Related Therapy
The CEO of GSK, Emma Walmsley, stated that the company has had a minimal role in the FDA's effort to approve a long-shelved drug for a condition often associated with autism.
During a panel discussion at the STAT Summit, Walmsley described the FDA's request to update the prescribing information for the decades-old therapy leucovorin as "an administrative request".
"We have no commercial interest, we have no scientific research, and we’re not pursuing it,"
she added, emphasizing that the company's involvement is limited to administrative tasks.
The FDA's initiative aims to update the prescribing information for leucovorin to allow its use in treating a condition associated with autism.
Author's summary: GSK plays down role in FDA autism therapy approval.
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