Recently, the State Food and Drug Administration of China issued the latest drug approval documents, and Aokeda Bio's Vigabatrin For Oral Solution was approved for marketing.

Vigabatrin is an analog of γ-aminobutyric acid (GABA) and has anti-epileptic effects. The drug can be used as an adjuvant therapy to treat patients who are ineffective against other antiepileptic drugs, especially patients with partial seizures (mainly used to control complex partial seizures). This medicine can also be used in babies with West syndrome (infantile spasms).

Vigabatrin was developed by Sanofi and launched in the U.S. in 2018. It is one of the few FDA-approved treatments for infantile spasms (IS) and some adults whose seizures cannot be controlled after using various epilepsy therapies. One of the drugs.

In China, Shanghai Aokeda Biotech and Dr. Ruidi of India have successively submitted the import application of category 5.2 of "Vivaroxenic Acid Powder" and included them in the priority review process on the grounds of "compliance with rare diseases and children's drugs". In addition, Yuandong, Chengdu, China, is reporting this product in the new three categories, and has now entered the second round of information issuance.

It is estimated that more than 10,000 newborns in China suffer from infantile spasms each year and require effective disease management. For the families of these patients, vigabatrin powder will meet an urgent medical need. After being dissolved in water, the product is convenient for infants and young children to take and adjust the dosage according to body weight, which is convenient for the target patient population to determine the dosage.

Currently abroad, Vigabatrin has replaced ACTH as the first-line treatment for infantile spasms. In 2018, the global sales of Vigabatrin were RMB 1.392 billion. It can be said that the research and development of Vigabatrin will have a vast market in the future.

TOSUN PHARM supplies Vigabatrin API for research and development. Welcome to consult.