Medipost announced on the 4th that its stem cell therapy for osteoarthritis, “Cartistem,” has received approval from the U.S. Food and Drug Administration (FDA) to proceed with a single Phase 3 clinical trial for marketing authorization. Given that the FDA typically requires results from two or more independent Phase 3 clinical trials in the new drug approval process, this is expected to significantly reduce development time and costs.

Medipost explained that it led to this decision by submitting to the FDA clinical trial results obtained in Korea and Japan, along with real-world evidence based on treatment data from approximately 560 domestic patients three years after administration. As a result, the number of patients in the U.S. Phase 3 trial will be cut by about half, from the original 600 to around 300, and the clinical trial period will be shortened from about 48 months to 42–45 months, potentially bringing forward the commercialization timeline. With the reduced trial scale, total development costs are also expected to decline by 20–30% compared with the original plan.

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