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FDA maintains COVID-19 therapeutics must meet a ‘gold standard’

Comes after President Trump called for expedited approval of potential treatments


The US Food and Drug Administration (FDA) has maintained that any therapeutics developed for COVID-19, the disease caused by the novel coronavirus, will need to meet the same ‘gold standard’ of any drug looking for approval.

The statement comes in response to remarks made by President Donald Trump, who asked the FDA to remove standard barriers between patients and access to coronavirus therapeutics.

Trump also asked for the approval of any new drugs for COVID-19 to be expedited – particularly those drugs that may already be approved but for different indications – such as Roche’s IL-6 inhibitor Actemra/RoActemra.

The FDA has said that while it is working closely with drug developers and partners for the speedy development of targeted treatments for the coronavirus, it will still ensure that any drug put forward to it meets “the agency’s world-respected gold standard”.

The agency said it would do this by “relying on data from adequate and well-controlled trials to most efficiently determine if an experimental treatment can safely and effectively benefit patients”.

It said that it is already working closely with other government agencies and academic institutions that are evaluating the efficacy of the drug chloroquine, which is already approved for use against malaria, lupus and rheumatoid arthritis.

The FDA has also been working with Gilead, whose investigational antiviral drug remdesivir is currently being tested in a randomised controlled trial by the National Institutes of Health (NIH) to determine if it is effective in the treatment of COVID-19 patients.

It is clear that although the FDA is working to fast-track the development of both therapeutics and vaccines for the treatment of COVID-19, it will only approve any treatment if the data supports widespread use and shows clear efficacy.

“We...must ensure these products are effective; otherwise we risk treating patients with a product that might not work when they could have pursued other, more appropriate, treatments,” said Stephen Hahn, FDA commissioner.

Speaking on the development of choloroquine for COVID-19, Hahn said: “If clinical data suggests this product may be promising in treating COVID-19, we know there will be increased demand for it.”

“We will take all steps to ensure chloroquine remains available for patients who take it to treat severe and life-threatening illnesses such as lupus,” he added.

Article by
Lucy Parsons

20th March 2020

From: Regulatory



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