FDA Helps Bring Autism Drug to Market The U.S. Food and Drug Administration (FDA) granted its “breakthrough therapy” designation to a drug that may improve social interaction and communication for people with autism spectrum disorder (ASD). The FDA uses the designation to speed the development of promising medications for serious conditions—in this case, balovaptan, manufactured by Swiss ... News in Brief
Free
News in Brief  |   April 01, 2018
FDA Helps Bring Autism Drug to Market
Author Notes
Article Information
Special Populations / Autism Spectrum / Regulatory, Legislative & Advocacy / News in Brief
News in Brief   |   April 01, 2018
FDA Helps Bring Autism Drug to Market
The ASHA Leader, April 2018, Vol. 23, 14. doi:10.1044/leader.NIB4.23042018.14
The ASHA Leader, April 2018, Vol. 23, 14. doi:10.1044/leader.NIB4.23042018.14
The U.S. Food and Drug Administration (FDA) granted its “breakthrough therapy” designation to a drug that may improve social interaction and communication for people with autism spectrum disorder (ASD).
The FDA uses the designation to speed the development of promising medications for serious conditions—in this case, balovaptan, manufactured by Swiss drug-maker Roche. The designation offers drug-makers added assistance and priority as they work to get a new treatment to market.
Although two drugs—risperidone and aripiprazole—have FDA approval to treat irritability related to ASD, there are no standard FDA-approved drugs for core ASD symptoms such as social interaction difficulties, communication challenges and a tendency to engage in repetitive behaviors.
Results from a 2017 clinical trial in adults with ASD indicate that balovaptan was safe, well-tolerated and successful in helping mediate challenging social behaviors. Another trial with children and adolescents on the spectrum is underway, and additional studies are in the works, according to Roche.
“We look forward to working closely with the FDA in the hope that we can bring this medicine to these individuals as quickly as possible,” says Sandra Horning, Roche chief medical officer.
0 Comments
Submit a Comment
Submit A Comment
Name
Comment Title
Comment


This feature is available to Subscribers Only
Sign In or Create an Account ×
FROM THIS ISSUE
April 2018
Volume 23, Issue 4