• The FDA issued an emergency use authorization for hydroxychloroquine and chloroquine April 27
  • Clinical trials could not replicate anecdotal evidence on the drugs' efficacy in treating COVID-19
  • President Trump had touted the drugs as a "game-changer" and even took a two-week regimen despite the heart risks

The Food and Drug Administration on Monday revoked its emergency authorization for using hydroxychloroquine and chloroquine to treat COVID-19, the lung condition caused by the coronavirus. President Trump had touted the anti-malarial drugs as a preventative and cure for COVID-19, which has killed more than 434,000 globally and nearly 116,000 in the United States by midday Monday.

Hydroxychloroquine is manufactured by Mylan (MYL), which was trading 0.66% lower at midday.

“FDA has determined that CQ [chloroquine]and HCQ [hydroxychloroquine] are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA [emergency use authorization],” FDA said in its alert.

The FDA said the drug’s dangerous side effects outweigh “the known and potential benefits.” The drugs caused heart rhythm problems.

“This warrants revocation of the EUA for [hydroxychloroquine] and [chloroquine] for the treatment of COVID-19,” the FDA said.

In a letter to the Biomedical Advanced Research Development Authority, the FDA said it was complying with BARDA’s request for the revocation, resulting from clinical trial data on the drug’s lack of efficacy. FDA said the drug, which also is used to treat rheumatoid arthritis and lupus, no longer meets emergency use requirements.

The FDA found dosing regimens for treating COVID-19 were “unlikely to produce” hoped-for antiviral effects, and use of the drugs did not produce results different from standard care.

“Recent data from a large randomized controlled trial showed no evidence of benefit for mortality or other outcomes such as hospital length of stay or need for mechanical ventilation of HCQ treatment in hospitalized patients with COVID-19,” FDA said.

“It is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks,” FDA added.

Trump had touted hydroxychloroquine as a “game-changer” in the fight against the coronavirus pandemic and took a two-week regimen of the drug after two White House staffers tested positive for the virus. Trump also sent 2 million doses of the drug to Brazil, where the outbreak is mushrooming.