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Trump calls on FDA to cut ‘red tape’ as coronavirus drug trials gather pace

A number of candidates begin trial testing

Clinical trial

President Donald Trump has asked the FDA to remove barriers to getting coronavirus therapeutics to patients, as the US government updated on progress with drug testing for COVID-19.

Trump wants the FDA to speed up approval of new drugs for the virus, particularly drugs that have been approved for other purposes that might have a role to pay in tackling the epidemic, although the agency has insisted it has to make sure treatments are safe and effective.

FDA Commissioner Stephen Hahn said the agency “needs to make sure that [we] will get the right drug to the right patient at the right dosage at the right time,” and that should occur in the context of a “large pragmatic clinical trial.”

There have been reports that Trump was considering an executive order to make experimental drugs more widely and readily available against COVID-19, but the FDA pushed back against that idea.

Drug news round-up

The comments came amid a number of developments in among COVID-19 drug therapies, notably early data suggesting that an old malaria drug – chloroquine and its derivative hydroxychloroquine – could be a treatment option.

Trump implied that the drug had been approved for use in COVID-19 at a press conference yesterday, but the FDA swiftly issued a statement stressing that it is still being tested clinically. Meanwhile, Bayer and Teva have said they will donate millions of tablets of the drug to the US for testing and compassionate-use purposes.

It has been suggested that hydroxychloroquine  may be able to reduce the duration of infection in patients with mild-to-moderate disease, cutting the number of patients who tested positive for the virus from 90% to 25% after six says in a small French study.

There was disappointing news after a clinical trial of AbbVie’s HIV therapy Kaletra (lopinavir/ritonavir) – conducted by doctors in China in 199 severely-ill COVID-19 patients – found no benefit when the drug was added to standard care.

The drug didn’t lead to an improvement in survival, the amount of virus carried by patients or the length of time they stayed in hospital, according to the results, which have been published in the New England Journal of Medicine. It has been suggested it might be premature to write the drug off however, as it might work better in milder cases and if treatment was initiated more quickly.

Earlier this week, Johnson & Johnson also said there was no evidence that its HIV drug Prezista (darunavir) – given on its own or alongside other HIV drugs, has any effect on COVID-19.

The company said it was responding to “unsubstantiated reports” saying the dug was effective, but added it was screening all its antiviral compounds for efficacy against coronaviruses.

Meanwhile, the FDA confirmed yesterday that 250 COVID-19 patients in the US have been treated with Gilead Sciences’ antiviral remdesivir, first developed as a potential Ebola treatment, as the agency collaborates with the company on clinical testing for coronavirus.

Turning to drugs that try to treat the respiratory inflammation that afflicts patients who get seriously-ill with COVID-19, Roche confirmed this week it has started a phase 3 trial of its Actemra/RoActemra (tocilizumab) in 330 hospitalised patients around the world.

The IL-6 inhibitor has been approved for emergency use in China since 3 March, and while independent trials are ongoing “this new trial is vital because there are no well-controlled studies and limited published evidence” backing use of the drug in this setting.

Annother IL-6 inhibitor – Sanofi and Regeneron’s Kevzara (sarilumab) – started clinical testing for COVID-19 earlier this month.

Finally, Merck KGaA has donated  a supply of its  interferon beta-1a product Rebif – approved for multiple sclerosis - to France’s INSERM research organisation following a request for use in a COVID-19 clinical trial.

Article by
Phil Taylor

20th March 2020

From: Regulatory

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