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Gilead halts individual requests for COVID-19 hopeful remdesivir

Will now focus on expanded access programmes and backlog


Since Gilead’s experimental antiviral drug remdesivir was identified as one of the most promising treatments against the novel coronavirus disease COVID-19, the pharma company has seen an influx of requests for access to the drug on compassionate use grounds.

Gilead has now had to suspend the acceptance of new individual compassionate use requests as it struggles to keep up with the increasing demand for the drug.

The company has, however, made an exception for compassionate use requests made for pregnant women and children under the age of 18 with a confirmed and severe case of COVID-19.

The pharma giant is already collaborating with the US National Institutes of Health (NIH) on a clinical trial of remdesivir as a treatment for seriously ill COVID-19 patients.

Although the drug was originally being evaluated for efficacy against Ebola, early data from animal studies has shown the drug has potential against Middle Eastern Respiratory Syndrome (MERS), another type of coronavirus.

Since then, experts and researchers across the world have been focusing on the use of remdesivir in the treatment of COVID-19, as pressure mounts for the discovery of a proven, effective drug.

The first patient to be diagnosed with the novel coronavirus in the US was treated with remdesivir via the compassionate use programme – treatment with the experimental drug was initiated on day seven of the patient’s stay in hospital.

Findings from that study, published in the New England Journal of Medicine, support the potential use of remdesivir as a COVID-19 treatment.

That data demonstrated that, on day eight, the patient’s condition had begun to improve after treatment with the experimental drug, and he was able to be taken off a ventilator, with his fever and cough also resolving.

Despite the promising data, it is still unclear whether remdesivir was the definitive factor in the US patient zero’s quick recovery.

The NIH trial is enrolling up to 1,000 patients to receive treatment with Gilead’s antiviral drug – the larger scale will be able to determine remdesivir’s definitive efficacy compared to the individual testimonies from compassionate use cases.

“We recognise the urgent need and are working to implement expanded access programmes as quickly as possible, with the continued support and collaboration of regulatory agencies,” Gilead said in a statement released yesterday.

Meanwhile, Roche has started phase 3 trial of its IL-6 inhibitor Actemra/RoActemra (tocilizumab) in 330 hospitalised patients around the world.

The trial initiation comes after China approved the drug for emergency use in critically ill COVID-19 patients on 3 March.

Article by
Lucy Parsons

23rd March 2020

From: Marketing



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