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EMA backs compassionate use of Gilead’s remdesivir for COVID-19

Drug has demonstrated activity against SARS-CoV-2 in laboratory studies

Gilead

The European Medicines Agency (EMA) has recommended compassionate use for Gilead’s experimental antiviral drug remdesivir as a treatment for severely ill COVID-19 patients.

Although remdesivir has limited data on its provable effectiveness against the novel coronavirus disease, the drug has demonstrated activity against SARS-CoV-2 – the virus which causes COVID-19 – in laboratory studies.

The recommendation follows a virtual meeting of the EMA’s human medicines committee (CHMP) where the committee provided clarification on how remdesivir should be used for treating COVID-19 in compassionate use programmes in the EU.

"Clinical trials remain the gold standard for the collection of robust data on the safety and effectiveness of investigational medicinal products, but the CHMP acknowledges the need for a harmonised approach to compassionate use in the EU to allow access to remdesivir for patients who are not eligible for inclusion in clinical trials,” said Harald Enzmann, chair of the CHMP.

Gilead’s antiviral has been at the centre of urgent research into identifying an effective therapeutic for COVID-19. While the drug had been made available via a compassionate use programme in the US, Gilead recently suspended individual requests to this programme after it was inundated with applications.

The company has instead launched an expanded access programme, which will allow physicians, hospitals and medical professionals to make requests for multiple patients at a time.

Remdesivir is being studied in a number of trials across the globe – Gilead started US testing of the drug in February. It is also being investigated in two Chinese trials, with results for these studies due in the next few weeks.

A pair of phase 3 studies were also launched in the UK last week, with one trial for severely ill patients and another for moderate cases. The trials were fast-tracked and awarded urgent public health research (UPHR) status by the Chief Medical Office.

A slew of other potential drugs are also being expedited through the research stages as global confirmed cases of the novel coronavirus top over a million. That includes the decades-old malaria treatment chloroquine, which was awarded an emergency authorisation by the US Food and Drug Administration (FDA) after President Donald Trump touted its efficacy against the novel disease.

The hope is to find an effective treatment for COVID-19 while the world awaits the development of a successful vaccine. Experts have warned that a vaccine is still at least 12-18 months away, although Moderna’s chairman Noubar Afeyan revealed last week that the company’s vaccine candidate could begin phase 2 human trials in spring or early summer.

Article by
PMGroup

7th April 2020

From: Research

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