Briviact(ingredient: brivaracetam), a third-generation antiepileptic treatment, has obtained domestic approval.
The new drug offers better and quicker absorption than existing medicines to alleviate seizures. The pharmaceutical industry is paying attention whether it will bring a change in the epilepsy treatment market in Korea.
The Ministry of Food and Drug Safety granted the green light to UCB Korea’s Briviact in four different dosing, on Monday.
Briviact is indicated as a supplementary treatment for partial seizures with or without secondary systemic seizures in patients 16 years of age and older with epilepsy. Patients can take the medication twice a day. The drug comes in both liquid and tablet forms. The approval was given for Briviact 10mg, 25mg, 50mg, and 100mg.
Epilepsy is caused by a sudden dysfunction of nerve cells in the brain. It repeatedly occurs even when no physical abnormality causes an epileptic seizure.
Briviact was developed by UCB as a third-generation antiepileptic drug, after the first-generation drug Keppra (levetiracetam) and the second, Vimpat (lacosamide). The latest medication alleviates seizures quickly, with an absorption capacity 20 times stronger than conventional treatments.
The U.S. Food and Drug Administration gave the nod for Briviact as an epilepsy treatment in February 2016 and allowed the indication expansion as monotherapy and a supplementary therapy to treat partial seizures in pediatric patients four years of age and older with epilepsy in May 2018.
The local approval for Briviact does not include the indication for young patients.
UCB Korea released Keppra and Vimpat in Korea and has led the antiepileptic treatment market.
Keppra is still an important antiepileptic drug, which sold 25.8 billion won ($22.9 million) in 2018, according to UBIST’s preliminary data.
However, UCB Korea did not earn satisfactory results in the drug pricing negotiations for Vimpat with the government. The company withdrew Vimpat from the market in May 2018.
Vimpat was replaced by generic drugs such as SK Chemical’s Vimsk Tab.