Grandbrothers The U.S. FDA has picked fosigotifator, an investigational therapy targeted at a brain disorder called Vanishing White Matter (VWM) disease, for its START Pilot rare disease program, Calico Life Sciences, which develops the treatment with AbbVie ( NYSE: ABBV ), announced Friday.
Launched in 2023, the FDA’s START Pilot Program, also known as Support for Clinical Trials Advancing Rare Disease Therapeutics (START), is designed to accelerate the development of rare disease treatments. The developers of drugs selected for the START Pilot Program are allowed to frequently interact with the FDA reviewers when they seek clarity on R&D issues such as clinical study design and targeted patient groups. VWM disease is an ultra-rare brain disorder with no FDA-approved therapies.
A Phase 1b/2 trial conducted by AbbVie ( ABBV ) and Calico is currently underway for fosigotifator in patients with VWM disease. More on AbbVie AbbVie: Turnaround Lurking After The Correction Pain (Upgrade) AbbVie: This Dividend Aristocrat Is Almost Buyable Again Now Looking For Both Income And Growth? 4%-Yielding AbbVie Has You Covered AbbVie succeeds in mid-stage trial for ovarian cancer drug, Elahere AbbVie doses first patient in phase 3 trial of multiple myeloma asset.