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Mexico will not follow FDA in approving Gilead's coronavirus drug

Christian Fernsby ▼ | October 24, 2020
Mexico will not necessarily follow the U.S. Food and Drug Administration (FDA) in approving Gilead Science Inc’s antiviral drug remdesivir for use in coronavirus patients, a top Mexican health official Hugo Lopez-Gatell said on Friday.
Hugo Lopez-Gatell
Mexico   Hugo Lopez-Gatell
Mexico’s health regulator Cofepris has already twice denied approval for the drug with a “non-favorable” opinion, deputy health minister Hugo Lopez-Gatell told his regular nightly news conference.

Topics: Mexico

“We have no mandate from the FDA,” he said. “Cofepris has identified that the evidence does not suggest a usefulness, a sufficient efficacy.”

The FDA approved remdesivir on Thursday, making it the first and only drug approved for the disease in the United States.

Lopez-Gatell said Gilead had sent a letter to doctors in Mexico refuting the results of the Solidarity trial, and that officials were looking to see if the letter could be cause for sanction, given that remdesivir is not registered with Mexican health authorities.

“It confuses the population and generates a false expectation of the possibility of having a treatment option,” he said.


 

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