The Korean government has recently designated epilepsy drug Sabril (vigabatrin) as a national essential drug, following shortages experienced last year.

On Tuesday, the Ministry of Food and Drug Safety (MFDS) announced that vigabatrin has been newly designated as a national essential drug. Since 2016, the MFDS has been designating drugs essential for healthcare as national essential drugs and providing necessary administrative, financial, and technical support.

Sabril Tab. 500mg is the sole tablet version of vigabatrin licensed in Korea. Sabril, a treatment for epilepsy and infantile spasms developed by Sanofi, is exclusively distributed by Handok, which holds a domestic license. Handok imports the raw materials and manufactures the finished drug in Korea.

Infantile spasms primarily manifest within the first year of life, a critical developmental period for babies. Repetitive spasms during this time can adversely affect brain development, underscoring the importance of appropriate treatment to minimize developmental damage.

However, Sabril shortages are an ongoing problem in hospitals.

Last year, the Korea Children's Hospital Association reported that drugs, including Sabril, used to treat severe pediatric illnesses, have been out of stock for more than a year.

In July last year, concerns regarding the local shortage of Sabril supply intensified when Handok recalled some batches of Sabril due to the detection of an unauthorized ingredient.

Also on Tuesday, the regulator designated another seven new national essential drugs. These eight medicines, including Sabril, are primarily used for pediatric patients and pregnant women, with limited substitutes available. 

With this new designation, the total number of nationally essential drugs has expanded to 416 ingredients.

The new national essential drugs include ganciclovir injection, milrinone injection, vigabatrin tablet, human protein C injection, cefiderocol injection, cholestyramine resin suspension acid, propranolol tablet, and hydralazine injection.

Among these, cefiderocol injection, an antibiotic for treating multidrug-resistant bacterial infections, is not licensed in Korea. 

In 2022, Jeil Pharmaceutical signed a deal with Japan's Shionogi Pharmaceutical to exclusively develop and commercialize it in Korea.