- The European Commission has designated Orphan Drug tag to Forma Therapeutics' (NASDAQ:FMTX) FT-4202 for the treatment of sickle cell disease (SCD). The product candidate was previously granted Fast Track, Rare Pediatric Disease and Orphan Drug designations in the U.S. for SCD.
- The designation provides financial and regulatory incentives to the sponsor company and 10 years of market exclusivity.
- The company prepares to initiate a Phase 2/3 trial with FT-4202 in 1Q of 2021, and is currently enrolling patients with SCD in a Phase 1 study to evaluate the safety and pharmacokinetics/pharmacodynamics of FT-4202.