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Stem Cell Therapy
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CDMO Business
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Kangstem Biotech strives to develop an innovative new drug for patients suffering from rare and incurable diseases.
News of approval for the use of AD 2nd medication for treatment purposes
25
2024.06
Kangstem Biotech's stem cell therapy for atopic dermatitis, Furestem-AD Inj., has been approved for therapeutic use for a second dose by the Korean Ministry of Food and Drug Safety.
Kangstem Biotech's stem cell therapy for atopic dermatitis, Furestem-AD Inj., has been approved for therapeutic use for a second dose by the Korean Ministry of Food and Drug Safety. Therapeutic use authorization is a system that allows the use of drugs under development to provide treatment opportunities for emergency patients with life-threatening conditions or no alternative treatment options.
This is the second therapeutic use authorization for Furestem-AD, and the same patients are being treated at the same institution as those who received the authorization in April. "A patient with atopic dermatitis who had not responded to existing antibody therapies for more than six months and had worsened despite using them, showed good EASI(Eczema Severity Assessment Score) improvement after the first dose of Furestem-AD," said Hanlim University's Gangnam Sungshim Hospital, which applied for the approval. "However, the patient's disease severity was judged to be so severe that a high improvement of EASI75 or higher was needed quickly, so a second dose was applied for.“
"Severe patients with high EASI scores may still be moderately ill, even with a 50% improvement, which may have led to the healthcare organization's quick decision to initiate a second dose. We will work to expedite the second dose for these patients.
Furestem-AD Inj., has an excellent safety record, with safety data on more than 500 patients in clinical trials, and no adverse events have been identified in the Phase 3 clinical trial, which is currently analyzing the data. In addition, the EASI50 achievement rate at one year from the first dose is 72% and the EASI75 achievement rate is 53%, and the EASI75 achievement rate is at the level of global antibody therapies on the market, so we have high expectations for the results of the Phase 3 clinical trial and the future competitiveness of the drug.
Kangstem Biotech plans to continue to monitor patients' disease status and improvement after treatment.