South Korea said on Wednesday it has approved the emergency use of Gilead Sciences Inc's remdesivir to treat COVID-19 after a government panel last week cited positive results for the anti-viral drug in other countries. While Gilead stated that this was done to protect patients from the drug's unknown side effects, physicians argue that excluding the sickest patients from clinical trials bias the data. The patents who received five days of remdesivir did best, with 76 percent improving by at least one point by day 11, compared with 66 percent who received standard of care. That's the bipharmaceutical company's antiviral treatment for COVID-19 that so far has been the only drug that has been shown to help patients suffering from the virus. A study from the New England Journal of Medicine found that 68% of Covid19 patients who received the drug showed an improvement, and 57% were able to come off ventilators.
It is approved for treating COVID-19 in Japan and is authorized for emergency use in the United States for certain patients.
Hospitalized patients with confirmed COVID-19 infection and evidence of pneumonia without reduced oxygen levels were randomized (1:1:1) to receive open-label remdesivir for five or 10 days or standard of care alone.
The open-label phase III SIMPLE study evaluated five-day and 10-day courses of remdesivir plus standard of care as compared to only standard of care in these patients.
In a note to investors, Evercore ISI analyst Umer Raffat noted that the study's main goal was changed partway through, from the percentage of patients discharged within two weeks to the scale of improvement after 11 days.
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Gilead says that a higher proportion of patients in the 5-day cohort achieved improvements in clinical status versus standard care. Those results are expected in the next few months.
"These study results offer additional encouraging data for remdesivir, showing that if we can intervene earlier in the disease process with a 5-day treatment course, we can significantly improve clinical outcomes for these patients", Harvard Medical School professor and Brigham and Women's Hospital infectious disease physician Francisco Marty said in a statement.
The ministry said it will cooperate with Gilead, the Korea Centers for Disease Control and Prevention and other ministries to swiftly import the drug. It's not known yet if it's a safe an effective COVID-19 treatment.
Now, given the spike in COVID-19 cases and the lack of a proven therapy, Dr. VG Somani, the Drugs Controller General of India, has approved Remdesivir for "restricted emergency use".