On October 22, Eastern time, the US FDA officially approved Gilead’s antiviral Veklury (remdesivir) for use in adults 12 years and older and weighing at least 40 kg in need of hospitalization and COVID-19 treatment. According to the FDA, Veklury is currently the only FDA-approved COVID-19 treatment in the United States.
Affected by this news, Gilead shares rose 4.2% after the market. It is worth noting that Trump has previously publicly stated that Remdesivir is “an important treatment for hospitalized patients with new coronary pneumonia” and urged the FDA to approve the drug urgently. After he was diagnosed with new coronary pneumonia, he also accepted Remdesivir.
According to the “Financial Times” report, scientists expressed concern about the approval. Such concerns are due to the fact that the US presidential election will be held in the next two weeks. The FDA’s approval may be due to political pressure, and it is necessary to demonstrate the government’s Actively respond to the epidemic. In May of this year, former US President Barack Obama criticized the Trump administration’s response to the new crown pneumonia epidemic, calling it a “completely chaotic disaster.“
In addition to political factors, at the WHO’s routine press conference for new coronary pneumonia on October 16, WHO Director-General Tedros said that the mid-term results of the “solidarity test” showed that remdesivir and hydroxychloroquine , Lopinavir/ritonavir and interferon therapy seem to have little effect on the 28-day mortality rate or the length of the hospital stay in hospitalized patients. The WHO trial showed that Redecivir hardly works in severe cases. 301 of the 2743 critically ill patients in the Redecive group died, and 303 of the 2708 critically ill patients in the control group died; the mortality rate was 11, respectively. % And 11.2%, and the 28-day mortality curve of Remdesivir and the control group are highly overlapped, and there is almost no significant difference.
But before the results of this solidarity and mutual aid test came out, Gilead submitted it for approval in August.
The approval of Remdesivir is based on the results of three randomized controlled clinical trials that included patients who were hospitalized due to the severity of COVID-19. A randomized, double-blind, placebo-controlled clinical trial conducted by the National Institute of Allergy and Infectious Diseases evaluated the time it takes for patients to recover from COVID-19 within 29 days of receiving treatment. The trial observed 1062 patients with mild, moderate, and severe COVID-19 who were admitted to the hospital and received remdesivir (541 people) or placebo (521 people), plus standard treatment. The median time to recovery from COVID-19 was 10 days in the remdesivir group and 15 days in the placebo group, and the difference was statistically significant. In general, compared with the placebo group, the chance of clinical improvement on day 15 in the Remdesivir group was statistically significantly higher.
The head of the FDA, Stephen Hahn, said that this approval is supported by data from multiple clinical trials that the agency has rigorously evaluated and represents an important scientific milestone for the new crown pandemic.