NDATOPICALGELPriority Review
Approved
Dec 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
1
Mechanism of Action
12.1 Mechanism of Action The mechanism of action of FILSUVEZ in the treatment of wounds associated with epidermolysis bullosa is unknown. 12.2 Pharmacodynamics Pharmacodynamics of FILSUVEZ are unknown. 12.3 Pharmacokinetics Absorption Systemic exposure to betulin was assessed in the 66 evaluable…
Clinical Trials (1)
A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez
Started Dec 2024
580 enrolled
Epidermolysis Bullosa, DystrophicEpidermolysis Bullosa, Junctional
Loss of Exclusivity
LOE Date
Jan 4, 2039
156 months away
Patent Expiry
Jan 4, 2039
Exclusivity Expiry
Dec 18, 2030