This new treatment is specifically indicated as a monotherapy for paediatric patients aged one month to two years with IS, provided the potential benefits justify the risk of vision loss.
The company anticipates VIGAFYDE will be available in the latter half of 2024.
Vigabatrin operates by inhibiting the GABA transaminase enzyme, which leads to an increase in gamma-aminobutyric acid levels in the brain.
This mechanism is essential for controlling seizures by modulating neuronal excitability.
Vigabatrin’s importance is further highlighted by ongoing research that suggests potential roles in reducing neurodevelopmental complications associated with certain epilepsy syndromes.
Pyros Pharmaceuticals co-founder and chief operating officer Edwin Urrutia said: “This is a momentous day for patients and caregivers who have long awaited the first ready-to-use vigabatrin.
“I believe this approval will bring renewed energy and momentum to the infantile spasms community, enhancing our efforts to improve disease education, develop care pathways, and expand investment in infantile spasms research.”
IS represents a rare and severe epilepsy form, typically emerging in children under one year.
Characterised by subtle, repetitive movements, IS can be easily missed or misdiagnosed.
Without proper treatment, IS may result in persistent seizures, other epilepsy forms, autism spectrum disorder, and developmental delays.
With the FDA’s endorsement, Pyros Pharmaceuticals is set to make a substantial impact on the management of IS.
Pyros Pharmaceuticals co-founder and CEO Michael Smith said: “The approval of VIGAFYDE marks the first new drug indicated for infantile spasms in 15 years and underscores our unwavering commitment to supporting families facing this challenging condition.”