[Photo by Yonhap]
Celltrion’s Covid-19 antibody therapy Rekirona and AstraZenecar’s coronavirus vaccine are being reviewed for potential emergency use authorization after passing preliminary evaluation, moving a step closer to advisory panel review for approval.
South Korea’s health authorities said Monday that clinical study results of Rekirona and the AstraZenecar Covid-19 vaccines are under review, and an expert panel will be formed next week to look into their clinical efficacy, safety and dosing rationale submitted to the Ministry of Food and Drug Safety.
Celltrion completed Phase 1 and 2 clinical trials of its genetically modified neutralizing antibody therapy called Rekirona (regdanvimab) in Korea.
Two Phase 1 trials involved 32 healthy volunteers and 18 Covid-19 patients with mild symptoms, respectively, to evaluate the drug’s safe dosage levels and side effects. One Phase 2 study was conducted in 327 patients with mild to moderate symptoms to evaluate the safety and efficacy of Rekirona. Levels of patient symptoms were recorded after treatment and time to transition from positive to negative for the virus was measured to compare the recovery speed between treatment and comparator groups.
The Phase 2 study was also designed to include part of Phase 3 endpoints such as the proportion of patients who require hospitalization and oxygen treatment to get more insights about the drug as a potential cure for the disease.
Last week, two teams from the ministry had a field investigation into Celltrion’s two manufacturing sites where Rekirona will be produced to check integrity of facility and quality management systems.
For AstraZeneca’s vaccine, the Korean authority plans to review its protection against the virus and the validity of vaccine dosing and administering based on clinical data. A field investigation will soon follow at SK Bioscience which will manufacture the vaccine for AstraZeneca in Korea.
AstraZeneca vaccine documents submitted for approval review include non-clinical and clinical trial results, quality, and risk management plans. The British pharmaceutical company applied for marketing approval of its Covid-19 vaccine with two doses (0.5ml each) given 4 to 12 weeks apart in people aged 18 years or older based on data from four Phase 2 and 3 trials conducted in the U.K., Brazil, and South Africa.
By Minu Kim
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