Emergency use authorization of Hydroxychloroquine revoked by U.S. FDA
Category: #health  By Pankaj Singh  Date: 2020-06-17
  • share
  • Twitter
  • Facebook
  • LinkedIn

Emergency use authorization of Hydroxychloroquine revoked by U.S. FDA

The malaria drug Hydroxychloroquine has been in the headline for the past few months. The drug was hailed as the game-changer in the treatment of COVID-19 by U.S. President Donald Trump. However, the U.S.FDA (Food and Drug Administration) has reportedly revoked its decision that allows emergency use of chloroquine and hydroxychloroquine for treating hospitalized people with COVID-19.

Based on the findings of emerging scientific data and ongoing analysis of EUA( Emergency Use Authorization), the agency concluded that hydroxychloroquine and chloroquine are not effective in the treatment of COVID-19.The clinical trials of malaria drugs also reported several serious adverse events such as high cardiac risk. The potential and known benefits of chloroquine and hydroxychloroquine no longer outweigh the potential and known risk for authorized use.

Previously, the U.S FDA granted the EUA on 28 March based on the findings of available data at the time. Today, BARDA (Biomedical Advanced Research and Development Authority) sent a letter to the agency requesting the cancellation of the EUA based on updated data.

Speaking on which, Anand Shah, M.D, Deputy Commissioner for Medical and Scientific Affairs at U.S FDA said that the agency’s decisions regarding EUA may evolve as per the updated data and considering the balance of risk against benefits for the treatment of COVID-19.

Mr. Shah added that the agency always underpins its decision-making with high quality, most trustworthy, and up-to-date evidence available. It would continue to evaluate all of the emergency use authorizations the U.S FDA has granted and made appropriate changes according to evidence, said Mr. Shah.

Hydroxychloroquine and Chloroquine are both U.S FDA-approved to treat or prevent malaria. Recent outcomes from several clinical trials showed that hydroxychloroquine has no benefits in the treatment of COVID-19 and suggested dosing regimens for hydroxychloroquine and chloroquine are unlikely to inhibit and kill the SARC-COV-2.

Source Credit -https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and



About Author

Pankaj Singh

Email: [email protected]   

Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

Read More

More News By Pankaj Singh

RADLogics obtains FDA's approval for AI-based chest X-Ray App
RADLogics obtains FDA's approval for AI-based chest X-Ray App
By Pankaj Singh

RADLogics Inc., a healthcare software company developing AI-powered solutions has reportedly received 510(k) clearance from the US FDA (Food and Drug Administration) for its latest AI-Powered chest X-ray pneumothorax a...

CDE of China NMPA clears I-Mab’s application for lemzoparlimab
CDE of China NMPA clears I-Mab’s application for lemzoparlimab
By Pankaj Singh

Clinical stage biopharmaceutical major, I-Mab, has reportedly announced that it has received the clearance of the Center for Drug Evaluation of the China National Medical Products Administration for its IND application...

Aoyuan Healthy to acquire 55% equity interest in Liantianmei
Aoyuan Healthy to acquire 55% equity interest in Liantianmei
By Pankaj Singh

Aoyuan Healthy Life Group Company Ltd., a renowned commercial property operation service and property management service provider based in China, has reportedly announced that Guangdong Xinyuerong Industrial Investment...