FDA Approves Vigafyde™ as the First and Only Ready-to-Use Vigabatrin Oral Solution
Pyros Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved Vigafyde™, the only ready-to-use vigabatrin oral solution, as a monotherapy for the treatment of pediatric patients 1 month to 2 years of age with infantile spasms (IS), where the potential benefits outweigh the potential risk of vision loss.
- Infantile spasms, a rare but severe form of epilepsy, pose significant challenges for patients and their families.
- Pyros provides ongoing personalized support to caregivers. The support program offers personal assistance and financial resources to caregivers whose child is starting or continuing therapy.
- Vigafyde™ is expected to be available in the second half of 2024.
