Anavex Life Sciences Corp (Nasdaq:AVXL) has received US orphan drug status in infantile spasms for a drug it is currently trialing to ease Alzheimer’s.
Anavex 2-73 is the second of the company’s projects to get ODD status, a designation the US Food and Drug Administration awards to fast track treatments for diseases that affect fewer than 200,000 people.
It gives Anavex a seven year window of commercial exclusivity in the US in the area of infantile spasms, prioritized consultation by the FDA on clinical studies and exemptions on some regulatory fees.
An infantile spasm is a specific type of seizure usually in the first year of life and typically between the ages of 4-8 months. Roughly 2-3 babies per 10,000 get them, with peak incidence at 6 months of age and less than 10% of cases presenting after 12 months of age.
Children with symptomatic spasms more frequently exhibit neurological deficits and cognitive and developmental delays, the company said.
Anavex 2-73 is the company’s lead candidate and currently in a Phase 2a clinical trial for Alzheimer’s disease.