Latest Orphan Drug Market Exclusivity News

AFT Pharmaceuticals has received tentative US FDA approval for its Scomara cream to treat Facial Angiofibromas in Tuberous Sclerosis, but US commercialisation is postponed until 2029 due to orphan drug exclusivity. The approval bolsters regulatory prospects in other key markets where AFT anticipates competitive advantages.

Dimerix Limited has announced a US licensing transaction for its Phase 3 asset DMX-200 targeting FSGS, alongside progress updates on its clinical trial. The move underscores the company’s push to address a rare kidney disease with no approved therapies.