FDA Withdraws Company’s Approval Of Drug Touted As Autism Treatment

U.S. regulators have withdrawn their approval of a GSK Plc drug that the Trump administration had promoted as a treatment for autism, adding another twist to the unusual story of a decades-old drug.

The Food and Drug Administration is pulling its approval of Wellcovorin, a branded version of leucovorin from GSK Plc, according to a post Thursday in the Federal Register. GSK had requested that the approval be withdrawn, the post said.

The FDA first approved leucovorin decades ago and it’s been used to blunt the side effects of chemotherapy for some cancer patients. In September, Trump administration officials endorsed the use of leucovorin as an autism treatment. Last month, the FDA approved its use for cerebral folate deficiency, which is seen in some people with autism.

GSK held the patent for Wellcovorin. At the FDA’s request, the company said in September it would seek approval for use of the drug for patients with cerebral folate deficiency. GSK’s approval was a procedural step necessary to make the generic version of the drug available.

By asking the FDA to withdraw Wellcovorin’s approval for cerebral folate deficiency, GSK will no longer be able to market it for that use. The generic version is still available to cerebral folate deficiency patients, the FDA said.

A FDA spokesperson said GSK’s action “does not affect the availability of generic leucovorin for patients with CFD, or the labeling of leucovorin products.”

GSK doesn’t make or sell Wellcovorin, or the generic equivalent.

“The label changes made to Wellcovorin will help enable generics already on market to add this new indication to their labelling,” GSK said in a statement Thursday.

With assistance from Rachel Cohrs Zhang and Madison Muller.

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