FDA Grants Fast-Track Status To Possible Autism Drug
For at least the second time this year, the Food and Drug Administration is moving to accelerate the approval process for a drug designed to address the core symptoms of autism.
Drugmaker Yamo Pharmaceuticals said this week that it received the FDA’s fast-track designation for a medication it’s developing called L1-79.
The decision comes after results from a small clinical trial found that the drug showed significant promise.
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“Preliminary data shows that within days of starting L1-79 therapy, there was a reduction in some patients’ irritability, lethargy, hyperactivity and anxiety, and improvements in speech, communication, socialization and awareness of themselves and others, resulting in improved behavior and better manageability of the patients,” according to the pharmaceutical company.
Currently, the FDA has approved two medications — risperidone and aripripazole — to address irritability associated with autism, but no drugs are approved to address the developmental disability’s core symptoms.
The fast-track designation is used to expedite the review of medications that “treat serious conditions and fill an unmet medical need,” according to the FDA. With the designation, drugmakers are assured more frequent communication with the regulatory agency and granted eligibility for a faster review process.
Earlier this year, the FDA granted a similar status — known as the breakthrough therapy designation — to another medication, balovaptan, developed by Roche that’s shown potential for improving “core social interaction and communication” in those with autism.
Yamo Pharmaceuticals said that additional clinical trials of L1-79 involving kids, adolescents and adults with autism are planned.
“This is an important and exciting step toward developing a much-needed treatment for the (core) symptoms of ASD,” said J. Thomas Megerian, Yamo Pharmaceutical’s chief medical officer and senior vice president of clinical development. “We look forward to working closely with the FDA and our advisors as we advance L1-79 through additional clinical studies.”