January 29, 2018 / 6:33 AM / 10 months ago

Roche wins FDA's breakthrough therapy designation for autism drug

ZURICH, Jan 29 (Reuters) - Swiss drugmaker Roche said on Monday the U.S. Food and Drug Administration granted its breakthrough therapy designation for Balovaptan to treat autism spectrum disorder (ASD), potentially accelerating its development and approval.

Balovaptan, which may improve social interaction and communication in people with ASD, is being developed by Roche’s Swiss-based research unit and has an expected filing date of after 2020, according to the company’s website.

“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,” said Roche Chief Medical Officer Sandra Horning. (Reporting by John Miller; Editing by Subhranshu Sahu)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below