REKOVELLE (compound: follitropin delta), the personalized subfertility treatment developed by Ferring Pharmaceuticals_페링제약, has won the approval of the Phase3 clinical trial plan in Korea.

The Ministry of Food and Drug Safety (MFDS) Monday approved the Phase 3 clinical trial proposal of “FE 999049(Recombinant FSH),” made by Quintiles Transnational Korea_{퀸타일즈트랜스내셔널코리아}. CHA Medical Center (CHAMC)_{분당차병원} and Asan Medical Center(AMC)_{서울아산병원} will conduct the trial. Target subjects are women who undergo assisted reproductive technologies, such as in-vitro fertilization and intracytoplasmic sperm injection cycle.

“FE 999049” is the clinical product name of REKOVELLE developed by Ferring Pharmaceuticals.

REKOVELLE is superovulation catalyst, and the first recombinant follicle-stimulating hormone (FSH) originated from human cells. This is also the first FSH to be administered using an individualized dosing regime based on Anti-Müllerian Hormone (AMH) level and body weight. AMH is a biomarker used to assess ovarian reserve and predict an ovarian response by controlled ovarian stimulation. The evaluation will be measured by Roche Diagnostics’_로슈진단 companion diagnostics kit, 'Elecsys AMH Plus' immunoassay.

The European regulators approved the sale of the drug in December, and the Phase 3 clinical trial seems to aim at winning approvals for Asian business.

According to the Evidence-based Stimulation Trial with Human recombinant FSH in Europe and Rest of the world (ESTHER) result of Phase 3 clinical test conducted by Ferring Pharmaceuticals, sustained pregnancy rate and sustained implantation rate were similar for women who suffered from subfertility and were treated with REKOVELLE. And the frequency for the optimal number of oocytes was higher for women who took the FSH therapy than the other case. Meanwhile, the FSH therapy caused less abnormal cases in ovarian response and controlled ovarian stimulation syndromes than the conventional treatment.

The ESTHER trials were randomized, controlled, assessor-blind, involving multi-organizations, and conducted in many countries, including Asian nations. And ESTHER was to compare the efficacy and safety of FE 999049 to the conventional treatment follitropin alfa in the case of controlled ovarian stimulation for subfertility women.