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 associated with autism.
"We have no commercial interest, we have no scientific research, and we're not pursuing it,"
Walmsley described the FDA's request to update the prescribing information for the decades-old therapy leucovorin as "an administrative request".
The company is not actively involved in the process, with Walmsley emphasizing that it is solely an administrative matter at this stage.
Author's summary: GSK plays down role in FDA autism therapy approval.
- Company: GSK
- Drug: leucovorin
- Condition: autism-related