FDA does not approve generic drug for autism
MADISON (WKOW) – Researchers are reacting to the FDA’s decision not to approve the prescription drug leucovorin for the treatment of autism.
The potential treatment was suggested by White House officials this past fall.
WKOW spoke with an expert regarding how this drug works.
Xin Yu Zhao, principle investigator at UW Health’s Waisman Center, studies vitamin B – specifically folic acid – and its critical role in neural development.
She emphasized that autism is a spectrum, and there’s no single drug that can treat all individuals.
Zhao explained that leucovorin can help treat a rare genetic condition involving individuals producing insufficient amounts of folic acid. “So [there] is a really, pretty specific…need [for] this drug – so it’s not really a drug for autism,” Zhao said.
On Tuesday, the FDA approved leucovorin for children and adults with this ultra-rare genetic condition. This decision follows an announcement by President Trump and FDA Commissioner Marty Makary that the drug was under review for autism patients. However, evidence only supported the drug’s use by patients with the rare mutation, not individuals with autism.
Since President Trump’s September announcement, prescriptions for leucovorin have surged. “I’m a parent too. So when your child is having this particular diagnosed situation, you will try everything… to help them,” Zhao said.
“Autism is a medical condition, it’s not a political condition,” Zhao said, encouraging people to trust their physicians and science.