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FDA pulls emergency OK for hydroxychloroquine in COVID-19

Data shows drug may reduce effectiveness of remdesivir


Mere weeks ago hydroxychloroquine was being hailed as a potential game-changer in COVID-19 treatment. Now, the FDA has pulled its emergency use authorisation (EUA) and relegated it to use in trials only.

Usually used to treat malaria, hydroxychloroquine and related drug chloroquine were granted an EUA in March for use in adolescent and adult COVID-19 patients who weren’t able to receive the medicines within clinical trials.

Since then, their star has steadily faded, despite ringing endorsements from President Donald Trump, who told reporters last month that he had been taking hydroxychloroquine prophylactically ward off the coronavirus.

Last week the results from the hydroxychloroquine arm of the large-scale RECOVERY trial run by the University of Oxford in the UK found no benefit from the drug when given to patients hospitalised with COVID-19, prompting one of the lead investigators – Prof Martin Landray – to describe the drug as “useless” for the coronavirus.

Another trial found no benefit when it is used as post-exposure prophylaxis, and there have also been concerns about its safety – and questions about the integrity of data that suggested it may be unsafe.

The final straw for the FDA seems however to have been new data showing hydroxychloroquine may interact with Gilead Sciences’ antiviral drug remdesivir that could reduce the latter’s effects against SARS-CoV-2, the virus that causes COVID-19.

Looking at data from the EUA programme, the US regulator has concluded that both hydroxychloroquine and chloroquine may reduce the effectiveness of remdesivir, which is the only drug approved so far to treat infection with the new coronavirus.

The FDA said the EUA has been revoked at the request of the Biomedical Advanced Research and Development Authority (BARDA), which has said new information has led it to conclude “that this drug may not be effective to treat COVID-19 and that the drug’s potential benefits for such use do not outweigh its known and potential risks”.

BARDA's former director Rick Bright claimed in April that he was sacked from his position at the agency after clashing with the Trump administration over its response to the coronavirus pandemic, and resisting its efforts to push the use of hydroxychloroquine.

In its notice revoking the EUA, the FDA said that the suggested dosing regimens for chloroquine and hydroxychloroquine “are unlikely to produce an antiviral effect”, adding that earlier signs of decreased viral shedding with treatment “have not been consistently replicated”.

Article by
Phil Taylor

16th June 2020

From: Regulatory, Healthcare



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