The Ministry of Food and Drug Safety announced on the 13th that it approved 91 types of medical products last month.
Among the newly approved medical products are the rare disease medications 'Tavalisse Tablets' (generic name fostamatinib), a treatment for thrombocytopenia, and 'Vyvgart Injection' (generic name efgaditamod-alpha), a treatment for myasthenia gravis.
Tavalisse Tablets were developed by the U.S. pharmaceutical company Rigel Pharmaceuticals, while the Japanese company Kissei Pharmaceutical secured the development and commercialization rights. JW Pharmaceutical signed a contract for domestic development and sales rights with Kissei Pharmaceutical. Vyvgart Injection is a treatment for myasthenia gravis, an autoimmune disease in which the patient's immune cells attack muscle. It was developed by the Dutch pharmaceutical company Argenx, and the Korean rights are held by HANDOK.
A new medical device, 'JDA-01K,' an artificial intelligence (AI)-based patient clinical information analysis support software, has been approved. This product helps determine the risk of developing diabetes based on clinical information such as sex, age, blood pressure, and genetic information. Approval details for other products can be checked through the electronic civil service system.
The number of newly approved medical products last month was 74.6% compared to 122 in the same month last year, showing a slight decrease.
The Ministry of Food and Drug Safety said, 'We will continue to quickly approve safe and effective products to expand treatment opportunities for patients,' adding that it will also strengthen the transparency and reliability of medical product approval reviews.