[Photo by Yonhap]
Celltrion Inc.’s Rekirona (regdanvimab), a genetically modified neutralizing antibody therapy to treat patients with Covid-19 symptoms, has moved a step closer for its marketing approval after an expert panel confirmed that the cure is effective in shortening time to recovery by three days.
The Ministry of Food and Drug Safety said on Monday the ad hoc expert panel of medical doctors and clinical statisticians recommended marketing authorization for the therapy on the condition that a Phase 3 trial should follow.
Data from a Phase 2 trial showed patients after treatment with Rekirona (given 40mg per 1kg of body weight) recovered in about 5.34 days, compared to 8.77 days for those in the placebo group. This 3.43-day faster recovery after treatment is clinically significant, the panel explained.
The panel also confirmed there were no serious adverse events attributed to the study medicine. Some patients reported hypertriglyceridemia and hypercalcemia, but they were predictable based on Phase 1 data. The adverse drug reactions were all mild or moderate in intensity and the occurrence of AEs was comparable between treatment and placebo groups.
As for Rekirona’s pharmacodynamic effects in the study, there was no statistically significant difference in time to virus negative from virus positive between the two groups.
Regarding the drug’s indications and clinical use, the panel recommended that the drug should demonstrate a significant reduction in severe symptoms to mild-to-moderate symptoms in a sufficient number of patients in a confirmatory Phase 3 study; treatment guidelines should be in place for clinical use after discussion with related institutions; and a separate clinical trial should be conducted to demonstrate the efficacy of Rekirona in comparison with existing treatments for severe Covid-19 symptoms or immunomodulators.
[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]