Trump pledges access to malaria drug chloroquine for COVID-19
President Donald Trump thrust a decades old malaria drug called chloroquine into the forefront of efforts to treat people with COVID-19 yesterday, saying the US would make it available “almost immediately”, even though it hasn’t been fully tested.
Chloroquine is already approved for treating malaria, lupus and rheumatoid arthritis, and is being used clinically in countries such as China and France to see if it can treat patients with mild or moderate COVID-19 infections.
Trump said yesterday that it was “approved for safety” and that the US government had “ordered a lot of it”, adding that it could be a “total game-changer” and would be available on prescription soon.
A subsequent FDA statement toned down the claims, noting the results of ongoing studies of chloroquine are still needed to determine its efficacy in treating the new coronavirus. The regulator also stressed that measures will be taken to make sure it will still be available for patients who currently rely on the drug.
Chloroquine could be made available on a compassionate use or ‘expanded access’ basis ahead of full regulatory approval for COVID-19.
The FDA says it is possible the drug could reduce the duration of symptoms and viral shedding, which could help prevent the spread of the disease.
That is backed up by a small study in 24 patients conducted at a hospital in Marseille, which found that after six days the virus was detected in 25% of chloroquine-treated subjects and 90% of untreated controls.
Trump’s call nevertheless seems to have galvanised action by pharma companies, with both Bayer and Teva saying they will donate chloroquine supplies to the US government to help test and deliver the drug.
Bayer is providing three million chloroquine tablets to the federal government and is seeking emergency use authorisation for the drug in the US.
Meanwhile, Teva has promised to deliver six million tablets of hydroxychloroquine sulphate – a derivative of chloroquine approved for the same indications – by the end of March and says it will be able to supply 10 million within a month at no cost.
“Although the product is not currently approved for use in the treatment of COVID-19, it is currently under investigation for efficacy against the coronavirus and has been requested by US government officials to be made available for use immediately,” said the Israeli drugmaker.
Trump also called on the FDA to cut the “red tape” to get COVID-19 therapies approved for widespread use more quickly, saying he had “directed the FDA to eliminate rules and bureaucracy so work can proceed rapidly.”
He also highlighted Gilead Sciences’ remdesivir, also in testing for the coronavirus, saying it was “close to approved”.
The FDA clarified that it has been working with the company to “find multiple pathways to both study the drug…as well as provide the drug to patients under emergency use”, adding around 250 people have been treated with the drug to date.
The agency also highlighted an ongoing trial of Regeneron’s IL-6 inhibitor sarilumab to see if it can mitigate the inflammatory response that leads to respiratory shutdown in some COVID-19 patients, and the use of antibody-rich blood products harvested from patients to fight the infection.
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