Neofect "Ybrain Depression Electronic Drug Approved for Market by MFDS... Leading Electronic Drug Innovation as 'First-in-Class'"

[Asia Economy Reporter Hyunseok Yoo] Ybrain, an affiliate of Neofect, has obtained the first-ever marketing authorization in the industry for an innovative first-in-class electronic medicine with an indication for the sole treatment of depression.

On the 28th, Ybrain announced that it received domestic marketing approval from the Ministry of Food and Drug Safety for an electronic medicine for depression treatment.

The obtained marketing authorization is not only an innovative drug indication allowing the sole use of electronic medicine for improving symptoms of major depressive disorder but also features prevention of misuse through electronic prescriptions and easy self-administration at home. Ybrain received the Minister of Trade, Industry and Energy Award in 2018 for related technology development and holds 48 registered patents domestically and internationally.

In September last year, Ybrain successfully completed Phase 3 clinical trials for the world’s first home-based sole treatment indication for depression. The efficacy and safety of symptom improvement treatment using TDCS (transcranial direct current stimulation) were evaluated in 65 patients diagnosed with mild to moderate major depressive disorder. After 6 weeks of application, 57.4% of all patients and 62.8% of protocol-compliant patients recovered to the normal range of depressive symptoms.

In the ‘2020 International tDCS Guidelines’ published by the International Journal under the Collegium Internationale Neuro-Psychopharmacologicum (CINP), Ybrain’s sole treatment for depression was assigned an evidence level of ‘A (definite efficacy)’. Accordingly, the possibility of listing in new medical technology assessments currently under review for sole treatment indications of depression is expected to be very high.

In the second half of this year, Ybrain plans to apply for the ‘De Novo procedure’ with the U.S. Food and Drug Administration (FDA) for its depression electronic medicine. The ‘De Novo procedure’ is used to approve new products that have demonstrated effectiveness and a certain level of safety among medical devices in the U.S. classification system but have no existing equivalent. Following Korea, it is expected to become an innovative drug in the U.S. as well.

A Ybrain official stated, “The commercialization of an electronic medicine platform capable of simultaneous application to hundreds of patients as a sole treatment for depression is the world’s first.” He added, “Non-pharmacological electronic medicine can provide a new treatment option for patients struggling with depression due to the efficacy limitations and various side effects of existing antidepressants. It is a technology that can address medical and social issues, such as Korea’s highest suicide rate among OECD countries despite mental health service utilization being less than half that of advanced countries.”

Meanwhile, the Korean Neuropsychiatric Association addressed transcranial direct current stimulation as one of the main symposium topics at its spring conference held on the 8th. The 2021 Korean Depression Treatment Guidelines presented at this conference mentioned transcranial direct current stimulation as a representative complementary and new treatment technology. The Korean Brain Stimulation Society is scheduled to publish official domestic guidelines for transcranial direct current stimulation in the second half of this year.