Pyros Pharmaceuticals, Inc. a leader in the development of enhanced specialty pharmaceuticals for rare diseases, is pleased to announce that VIGAFYDE™ (vigabatrin) oral solution is now available. VIGAFYDE™ is the first and only ready-to-use vigabatrin oral solution, 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. Please see full Prescribing Information below to view Important Safety Information, including BOXED WARNINGS.
AnovoRx has been designated as the exclusive specialty pharmacy for VIGAFYDE™, ensuring a streamlined process for patients and caregivers to access this critical treatment. Additionally, comprehensive support for families is provided through Pyros Total Care™.
“The availability of VIGAFYDE™ represents a significant advancement in the treatment landscape for infantile spasms. This ready-to-use formulation offers patients and caregivers a simpler dosing process and enhances the likelihood of accurate dosing of infants facing this very serious seizure disorder,” said Michael Smith, co-founder and Chief Executive Officer of Pyros.
“VIGAFYDE™ is more than just a new formulation; it’s a critical advancement in the treatment of infantile spasms that directly addresses the needs of both patients and caregivers. This launch reinforces Pyros' commitment to delivering innovative therapies that have a profound and lasting impact on the lives of those affected by rare pediatric epilepsies,” stated Edwin Urrutia, co-founder and Chief Operating Officer of Pyros.
About VIGAFYDE™ and Infantile Spasms
VIGAFYDE™ is a ready-to-use vigabatrin oral solution 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.
Infantile spasms (IS) is a rare, severe form of epilepsy that typically begins in children less than one year old. Early and accurate diagnosis, followed by timely treatment, is critical for improving long-term outcomes.
The U.S. FDA has approved a single shared system Risk Evaluation and Mitigation Strategy (REMS) for all vigabatrin products called the Vigabatrin REMS. This strategy is mandated by the FDA to ensure that patients and healthcare providers make informed risk-benefit decisions before starting treatment, and to ensure the proper use of vigabatrin throughout the treatment process.
Healthcare providers must be certified in the Vigabatrin REMS to prescribe VIGAFYDE™, and patients must be enrolled in the Vigabatrin REMS to receive VIGAFYDE™. Once certified and enrolled, prescribers and patients remain in the Vigabatrin REMS and do not need to undergo recertification or re-enrollment.
For more information, please visit: www.pyrospharma.com
