MEXICO CITY (Reuters) – Mexico is not going to essentially comply with the U.S. Meals and Drug Administration (FDA) in approving Gilead Science Inc’s antiviral drug remdesivir to be used in COVID-19 sufferers, a high Mexican well being official mentioned on Friday.

Mexico’s well being regulator Cofepris has already twice denied approval for the drug with a “non-favorable” opinion, deputy well being minister Hugo Lopez-Gatell informed his common nightly information convention.

“Now we have no mandate from the FDA,” he mentioned. “Cofepris has recognized that the proof doesn’t recommend a usefulness, a adequate efficacy.”

The FDA accepted remdesivir on Thursday, making it the primary and solely drug accepted for the illness in the USA.

Remdesivir, given intravenously, was one of many medication used to deal with U.S. President Donald Trump throughout his bout with COVID-19.

The World Well being Group’s (WHO) Solidarity drug trial final week concluded remdesivir has little or no impression on a affected person’s probabilities of surviving COVID-19, and a high WHO scientist on Friday beneficial the FDA contemplate all obtainable proof.

Lopez-Gatell mentioned Gilead had despatched a letter to medical doctors in Mexico refuting the outcomes of the Solidarity trial, and that officers have been seeking to see if the letter may very well be trigger for sanction, on condition that remdesivir will not be registered with Mexican well being authorities.

“It confuses the inhabitants and generates a false expectation of the potential of having a remedy possibility,” he mentioned.

Gilead didn’t instantly reply to a request for remark.

(Reporting by Sharay Angulo and Daina Beth Solomon; Modifying by Sonya Hepinstall and Tom Hogue)