Posted: Monday, October 6, 2025. 3:40 pm CST.
By Zoila Palma: U.S. Health Secretary Robert F. Kennedy Jr. may soon deliver a major policy victory for the Trump administration, as the Food and Drug Administration (FDA) moves to fast-track approval of a decades-old drug to treat an autism-related disorder, Reuters report.
The FDA has enlisted British pharmaceutical company GSK to expedite the process for leucovorin, also known as folinic acid, bypassing traditional requirements for new clinical trials or a lengthy label update.
The move, which could take just months, aims to officially recognize the drug’s use for cerebral folate deficiency, a condition that can cause neurological symptoms linked to autism.
GSK confirmed it plans to submit a new-use application for leucovorin “as quickly as possible,” after which the FDA could process the request in as little as four to six months.
The accelerated timeline aligns with Kennedy’s and Trump’s “Make America Healthy Again” agenda, which has emphasized rapid approval of treatments for neurological and developmental conditions.
While an HHS spokesperson defended the policy shift, saying the evidence supports leucovorin’s ability to improve outcomes, some medical experts described the decision as premature and potentially political. Harvard researcher Ameet Sarpatwari called it “a hollow bureaucratic victory” given the limited scientific data behind the drug’s use in autism-related conditions.
Interest in leucovorin has surged since President Trump publicly endorsed it following a CBS report about its use in a nonverbal child with autism.
Doctors say patient inquiries have soared, even though the drug is not approved for autism and is typically prescribed off-label.
Kennedy, who has called autism rates an “epidemic,” pledged earlier this year to find treatments and possible causes by September.
At a White House event on September 22, Kennedy and Trump both promoted leucovorin as a promising therapy while controversially warning pregnant women against using Tylenol — a claim that health experts have condemned as unsupported and dangerous.
The FDA’s ability to speed up leucovorin’s approval stems from an obscure rule that allows the agency to revive GSK’s 1990s-era application for its branded version, Wellcovorin, and update its label without requiring new trials.
Critics say the process, based on a review of just 40 patient cases, is “very atypical” and lacks transparency.
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Posted: Monday, October 6, 2025. 3:40 pm CST. By Zoila Palma: U.S. Health Secretary Robert F. Kennedy Jr. may soon deliver a major policy victory for
The post International News: U.S. Food and Drug Administration fast-tracks Autism-linked drug With GSK help appeared first on Belize News and Opinion on www.breakingbelizenews.com.
