The FDA granted fast track designation to Anavex Life Sciences’ (NASDAQ:AVXL) ANAVEX2-73 for the treatment of Rett syndrome.
Rett syndrome is a genetic neurodevelopmental disorder characterized by severe physical and intellectual impairments.
ANAVEX2-73, which has also received FDA orphan drug designation, is currently being evaluated in a Phase 2 trial. To-date, the trial has demonstrated significant improvements in Rett Syndrome Behaviour Questionnaire and Clinical Global Impression-Improvement scores.
“With no currently approved agents to treat Rett syndrome, patients and their physicians have an urgent need for new therapeutic options,” Christopher Missling, Anavex’s president and CEO, said in a statement.
“We view this FDA fast track designation as continued support that ANAVEX2-73 has the potential to address this unmet need,” he added.
