Mexico may not follow FDA and approve remdesivir for COVID-19

Mexico will not necessarily follow the US Food and Drug Administration (FDA) in approving Gilead Science’ antiviral drug remdesivir for use in COVID-19 patients, a top Mexican health official said.

Mexico’s health regulator Cofepris has already twice denied approval for the drug with a “non-favourable” opinion, deputy health minister Hugo Lopez-Gatell told his regular nightly news conference.

“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 last week, making it the first and only drug approved for the disease in the US.

The World Health Organization’s (WHO) Solidarity drug trial last week concluded remdesivir has little or no impact on a patient’s chances of surviving COVID-19, and a top WHO scientist recommended the FDA to consider all available evidence.

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.