Japan has started the treatment of COVID-19 patients using Gilead Sciences Inc’s remdesivir drug, days after the Health Ministry granted it regulatory approval. A government official has reportedly said that the treatment is being used on severely ill patients who are in intensive care or on ventilators.
On May 7, the ministry granted exceptional approval due to the COVID-19 pandemic and references the Emergency Use Authorization of Remdesivir in the United States. The approval was based on clinical data from the Phase 3 trial in the United States as patients who received the drug within 10 days of symptoms responded better to the treatment, according to the results announced by Gilead Sciences.
“The Japanese approval of remdesivir is in recognition of the urgent need to treat critically ill patients in Japan. It is a reflection of the exceptional circumstances of this pandemic,” Merdad Parsey, Chief Medical Officer, Gilead Sciences had said in a statement.
The US Food and Drug Administration (FDA) had earlier issued an Emergency Use Authorization for remdesivir for the treatment of COVID-19 due to ongoing health emergency. In the US, remdesivir is an investigational drug that has not been approved by the FDA for any use, and its safety and efficacy for the treatment of COVID-19 has not been established.
Parsey had said in a statement that the company is trying to evaluate an investigational agent alongside an evolving global pandemic. He said that multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilise the drug.
While the company’s CMO said that the study results complement data from a separate trial conducted by the National Institute for Allergy and Infectious Diseases, it didn’t disclose further details about the study. Gilead Sciences Inc. made it clear that remdesivir is not yet licensed or approved anywhere globally and has not yet been demonstrated to be safe or effective for the treatment of COVID-19.
(Image: Twitter / @JPN_PMO)