New FDA Approval: VIGAFYDE™ (vigabatrin) Oral Solution
The U.S. Food and Drug Administration (FDA) recentlhy approved VIGAFYDE™, the only ready-to-use vigabatrin oral solution. VIGAFYDE™ (vigabatrin) oral solution, is indicated 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.
Read the InpharmD summary below:
| Drug Name |
VIGAFYDE™ (vigabatrin) Oral Solution |
| Active Ingredient |
vigabatrin |
| Date of Approval |
June 17, 2024 |
| Manufacturer |
Pyros Pharmaceuticals, Inc. |
| Approval Pathways and Indications |
Approval Pathway: NDA
Indication: VIGAFYDE™ is indicated as monotherapy for the treatment of infantile spasms in pediatric patients 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss. |
| Therapeutic Class |
Anti-Epileptic |
| Formulation |
Oral Solution |
| MoA |
VIGAFYDE™ is an anticonvulsant that works in the treatment of infantile spasms by inhibiting the enzyme, gamma-aminobutyric acid (GABA) transaminase, consequently increasing GABA levels in the brain which is thought to enhance seizure control for patients by modulating neuronal excitability. |
| Dosing and Administration |
Initially, VIGAFYDE™ is administered at 50 mg/kg/day split into two doses of 25 mg/kg each. The dose may be increased by the healthcare provider if necessary every 3 days, in increments of 25 mg/kg/day to 50 mg/kg/day, up to a maximum daily dosage of 150 mg/kg (75 mg/kg twice daily). Use the provided oral syringe from the pharmacy to measure the exact dose. |
| Administered by self or by HCP |
Administered by self |
| Place in Therapy |
Infantile spasms is a rare, severe form of epilepsy that typically begins in children less than one year old, and can appear as subtle but repetitive movements that can be misdiagnosed. Infantile spasms can lead to long-term permanent issues such as continued seizures, other forms of epilepsy, autism spectrum disorder, and developmental issues.
Compared with other vigabatrin products, VIGAFYDE™ is a concentrated solution containing 100mg/mL of vigabatrin and requires a smaller volume than other vigabatrin products to obtain the same dosage (eg, currently available vigabatrin for oral solution products have a final concentration of 50mg/mL). It is important to verify the strength and the dose of the vigabatrin product prior to prescribing, dispensing and administering.
VIGAFYDE™ includes a boxed warning for risk of permanent vision loss, thus it is only available through the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program. |
| Expected Market Launch Date |
Availability is anticipated second half of 2024. |
| New Molecular Entity (NME) or Existing Formulation |
Existing Formulation |
| Expected Cost |
Unavailable |
| Product Discontinuation |
N/A |
| Clinical Trials |
VIGAFYDE™ was evaluated as monotherapy for infantile spasms in two pivotal multicenter studies. Study 1 included 221 infants under 2 years old with new-onset infantile spasms of various causes, randomized to receive either low-dose or high-dose vigabatrin for up to 21 days. The primary endpoint was achieving 7 consecutive days of spasm freedom within the first 14 days, with statistically significant results favoring the high-dose group (p=0.0375). Study 2, involving 40 patients, was a double-blind, placebo-controlled trial assessing the efficacy of VIGAFYDE™. While no initial significant difference was observed in spasm frequency reduction using a 2-hour evaluation window, a post-hoc analysis using a 24-hour window showed significant reduction in spasms in the VIGAFYDE™ group compared to placebo (p=0.030). An additional analysis from the Canadian Pediatric Epilepsy Network showed sustained response to VIGAFYDE™ in infants who continued treatment for 6 months with no recurrence of spasms thereafter. Common adverse reactions with VIGAFYDE™ included somnolence, bronchitis, and ear infections, with infections and neurological effects being most associated with treatment discontinuation. Dose-dependent adverse reactions were not clearly established. |
| |
Drugs.com. FDA Approves Vigafyde (vigabatrin) as First and Only Ready-to-Use
Vigabatrin Oral Solution. Available at: https://www.drugs.com/newdrugs/
fda-approves-vigafyde-vigabatrin-first-only-ready-vigabatrin-oral-solution-6306.html.
Published June 2024. Accessed June 21, 2024.
U.S. Food and Drug Administration. Vigafyde (vigabatrin)
[label information]. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/
2024/217684s000lbl.pdf.
Published June 2024. Accessed June 21, 2024. |
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