Aucta Pharma licenses Vigabatrin for Oral Solution in China
US headquartered Aucta Pharmaceuticals, Inc., a technology based company focusing on the development and commercialization of Branded Specialty Products, has announced that the Company has entered into an exclusive license agreement with Jiangsu Wanbang Biopharmaceuticals Group Co., Ltd., a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd., to license its China marketing rights for its U.S. FDA approved Vigabatrin for Oral Solution.
Aucta’s Vigabatrin for Oral Solution product was approved by U.S. FDA and launched in the U.S. market in July 2018. Vigabatrin for Oral Solution is one of the very few FDA approved effective treatment of infantile spasms (IS) and certain percent of adults with complex partial seizures (CPS) whose seizures remain uncontrolled in spite of having many antiepileptic therapies already available. Vigabatrin for Oral Solution and is not currently approved in China. Aucta is in the process of seeking its import drug license (IDL) with National Medical Products Administration (NMPA) (formerly China Food and Drug Administration or CFDA).
Vigabatrin for Oral Solution will fulfill a significant unmet medical need for pediatric patients with infantile spasms in China who require an NMPA approved medicine to effectively manage their condition. It is estimated there are more than 10,000 new-borns every year in China who have the condition of infantile spasms that would need an effective disease management. Vigabatrin for Oral Solution has the advantage of being body-weight adjustable and ease of dosing for the intended patient population.