Pyros Pharmaceuticals has received FDA approval for VIGAFYDE™, an oral vigabatrin solution for treating infantile spasms (IS) in pediatric patients aged 1 month to 2 years. IS is a rare and severe form of epilepsy with lasting effects.
VIGAFYDE™ is a monotherapy indicated where the benefits outweigh the potential risk of vision loss. The approval brings renewed enthusiasm to the IS community and will enhance efforts in disease education, care pathways, and research investments.
Michael Smith, Pyros CEO, emphasized the significance of VIGAFYDE™ as the first IS drug approved in 15 years, showcasing Pyros’ dedication to supporting affected families. Edwin Urrutia, Pyros COO, thanked stakeholders eagerly for anticipating this ready-to-use vigabatrin solution.
Pyros Total Care™, a comprehensive patient support program, offers personalized assistance to caregivers throughout the treatment journey, providing personal guidance and financial aid. This support system includes a nurse educator, reimbursement support, and a clinical pharmacist.
IS affects young children and can manifest in subtle, sometimes overlooked movements. Its potential long-term effects include seizures, autism spectrum disorder, and developmental issues. Early and effective treatment, as determined by a systematic American Academy of Neurology review, can positively influence long-term outcomes.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
