MedPath

FDA Revokes Emergency Use Authorization for Hydroxychloroquine in COVID-19 Treatment

• The FDA has revoked the Emergency Use Authorization for hydroxychloroquine and chloroquine to treat COVID-19, citing ineffectiveness based on emerging data. • The decision was influenced by data showing the drugs are unlikely to be effective against COVID-19 and pose potential cardiac risks. • Clinical trials indicated that hydroxychloroquine did not reduce mortality, hospital stay, or the need for mechanical ventilation in COVID-19 patients. • International bodies and other countries, including France, Italy, and Belgium, have already halted the use of hydroxychloroquine for COVID-19 treatment.

The U.S. Food and Drug Administration (FDA) has revoked the emergency use authorization (EUA) for hydroxychloroquine and chloroquine, previously allowed for treating certain hospitalized patients with COVID-19. This decision follows mounting evidence indicating the drugs' ineffectiveness and potential risks.

Efficacy Concerns

The FDA determined that the legal criteria for issuing an EUA were no longer met, based on ongoing analysis and emerging scientific data. The agency concluded that hydroxychloroquine and chloroquine are unlikely to be effective in treating COVID-19 for the authorized uses specified in the EUA. Earlier observations suggesting decreased viral shedding were not replicated in larger trials.

Safety Risks

In addition to efficacy concerns, the FDA highlighted the risk of serious cardiac adverse events and other potential side effects associated with hydroxychloroquine. The agency stated that the known and potential benefits of using chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use in treating COVID-19.

Clinical Evidence

Clinical data revealed no reduction in mortality, length of hospital stay, or need for mechanical ventilation in COVID-19 patients treated with hydroxychloroquine. Oxford University’s professor Martin Landray, co-leading the RECOVERY trial, stated that the drug is "useless" in treating COVID-19.

Regulatory Context

FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah, MD, emphasized that the FDA's actions are guided by science and that decisions evolve as more is learned about the SARS-CoV-2 virus. The FDA will continue to examine all emergency use authorizations and make changes based on emerging evidence.

Global Response

Several countries, including France, Italy, and Belgium, had already moved to halt the use of hydroxychloroquine for treating COVID-19 patients, aligning with the growing consensus on its lack of efficacy and potential risks.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

Second University of Minnesota Study Shows No Hydroxychloroquine Benefit in COVID-19 Fight

A second University of Minnesota study has found that hydroxychloroquine, an anti-malaria drug once championed by President Donald Trump, does not provide substantial benefits in treating COVID-19. The study compared outcomes of patients taking hydroxychloroquine with those taking a placebo and found no significant differences in death rates, hospitalizations, or persistent symptoms. The findings add to the growing evidence against the use of hydroxychloroquine for COVID-19 treatment.

FDA Bans Use of Lilly, Regeneron COVID Drugs Due to Omicron

The FDA has restricted the use of COVID-19 antibody therapies from Eli Lilly and Regeneron, citing their ineffectiveness against the Omicron variant. This decision impacts the emergency use authorizations previously granted for these treatments, as nearly all new COVID-19 cases in the U.S. are now caused by Omicron.

FDA Revokes Emergency Use Authorization for Sotrovimab

The FDA has revoked the Emergency Use Authorization (EUA) for sotrovimab due to the expiration of all manufactured lots under EUA 100.
GSK requested the EUA revocation on November 22, 2024, as sotrovimab was not authorized for use against non-susceptible SARS-CoV-2 variants.

FDA Revokes Authorization of GSK and Vir's Sotrovimab Due to BA.2 Inefficacy

The FDA has fully revoked the emergency use authorization for GlaxoSmithKline and Vir Biotechnology's sotrovimab due to its reduced efficacy against the Omicron sub-variant BA.2.
Sotrovimab initially received EUA based on Phase III trial data showing an 85% reduction in hospitalization or death risk for high-risk COVID-19 patients.

Hydroxychloroquine Shows Moderate COVID-19 Prevention in Large Clinical Trial

A large, double-blind, placebo-controlled trial (COPCOV) found a 15% reduction in symptomatic COVID-19 with hydroxychloroquine compared to placebo.
The study also demonstrated a significant reduction in all-cause respiratory illness and fewer workdays lost due to illness among those taking hydroxychloroquine.

FDA Revokes Emergency Use Authorizations for Four Monoclonal Antibody Treatments Due to Variant Resistance

The FDA has revoked the Emergency Use Authorizations (EUAs) for four monoclonal antibody (mAb) products previously used to treat COVID-19 due to persistent resistance from circulating SARS-CoV-2 variants.
These mAbs have not been authorized for patient administration for over a year because of the high prevalence of SARS-CoV-2 variants against which they are ineffective.

FDA Revokes Emergency Use Authorization for Evusheld Due to Variant Ineffectiveness

The FDA has revoked the emergency use authorization for Evusheld (tixagevimab/cilgavimab) in the U.S. due to its reduced efficacy against emerging SARS-CoV-2 variants.
Recent data indicates that Evusheld is unlikely to be effective against current dominant variants, such as XBB.1.5, which account for the majority of new infections.

FDA Withdraws Original COVID-19 Vaccine Authorization, Focuses on Bivalent Boosters

The FDA has withdrawn the emergency use authorizations for the original Moderna and Pfizer-BioNTech COVID-19 mRNA vaccines.
Updated bivalent vaccines targeting original and Omicron BA.4/BA.5 strains are now authorized for all doses in individuals six months and older.

FDA Restricts Sotrovimab Use Due to Omicron BA.2 Variant Resistance

The FDA has suspended the authorization of GlaxoSmithKline and Vir Biotechnology's sotrovimab in regions where the Omicron BA.2 subvariant is dominant, citing inefficacy.
Sotrovimab, a monoclonal antibody, was previously authorized for treating high-risk COVID-19 patients but shows reduced effectiveness against the BA.2 subvariant.

Hydroxychloroquine Fails to Prevent or Treat COVID-19 in Multiple Trials

A University of Minnesota study found that hydroxychloroquine did not prevent COVID-19 infection in high-risk healthcare workers, with 5.9% of the hydroxychloroquine group and 7.9% of the placebo group developing the virus.
The NIH's ORCHID trial concluded that hydroxychloroquine provides no clinical benefit to hospitalized adults with COVID-19, with similar health status observed in both hydroxychloroquine and placebo groups after 14 days.

Reference News

[1]
FDA defies Trump and revokes emergency authorisation for hydroxychloroquine
pharmaphorum.com · Jan 14, 2025

The FDA revoked hydroxychloroquine's Emergency Use Authorization for COVID-19, citing lack of benefits and potential ris...

[2]
FDA defies Trump and revokes emergency authorisation for hydroxychloroquine
pharmaphorum.com · Jun 15, 2020

The FDA revoked hydroxychloroquine's Emergency Use Authorization for COVID-19, citing lack of benefits and potential ris...

[3]
FDA revokes authorization of drug Trump touted for Covid-19
tradearabia.com · Dec 31, 2024

The FDA revoked emergency use authorization for chloroquine and hydroxychloroquine in treating Covid-19, citing lack of ...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy