GSK withdrew its application for the drug leucovorin (brand name Wellcovorin) on April 9 2026. The drug had been promoted by members of the Trump administration as a potential treatment for autism, but the FDA’s label update only authorizes its use for cerebral folate deficiency, a rare genetic neurological condition, and explicitly excludes autism indications.
The withdrawal is procedural; GSK stopped marketing leucovorin in 1999 and has never intended to revive it. Removing the application eliminates a theoretical revenue source, but the impact on GSK’s financials is negligible because the drug has not been sold for decades.
The action follows a label update that allows generic versions of leucovorin to be marketed for cerebral folate deficiency while maintaining the exclusion of autism. Generic manufacturers continue to supply the drug for the approved indication.
GSK’s Q4 2025 results showed sales up 7% to over GBP 32 billion, core operating profit up 11%, and earnings per share up 12%. The company’s 2026 guidance—sales growth of 3‑5% and operating profit and EPS growth of 7‑9%—remains unchanged, indicating that the withdrawal does not alter its outlook.
No market reaction or analyst commentary was reported. The event is a routine regulatory update with no safety concerns.
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