Cumberland Pharmaceuticals (NASDAQ: CPIX) has received Fast Track Designation from the FDA for its novel oral therapy targeting a fatal form of heart disease in Duchenne muscular dystrophy (DMD) patients.
The FDA has also previously granted ifetroban Orphan Drug Designation and Rare Pediatric Disease Designation.
In a statement, A.J. Kazimi, founder and CEO of Cumberland, commented, “The FDA’s Fast Track Designation for ifetroban underscores the urgent and critical unmet medical need in DMD heart disease. This designation, combined with our breakthrough Phase 2 results, positions us to work closely with the FDA through more frequent interactions and expedited review processes to advance this promising heart-targeted therapy for DMD patients as efficiently as possible. We look forward to engaging with the Agency and our patient advocacy partners to bring this much-needed therapy to DMD patients and their families.”
