European Union regulator promises speedy review of potential COVID-19 drug remdesivir

Marco Green
May 31, 2020

Use of the drug was supported by the government's Medicines and Healthcare products Regulatory Agency (MHRA) through the Early Access to Medicines Scheme, which allows patients with life-threatening illnesses to have access to unlicensed drugs in emergency situations.

The European Medicines Agency (EMA) noted it has not yet received an application from the US drugmaker, but said its human medicines committee's (CHMP) timeline to assess the drug would be "reduced to the absolute minimum", (https://bit.ly/2ZPh6HA).

The study will pair Roche's immune suppressor Actemra along with Gilead's antiviral remdesivir, the only drug shown so far to fight the coronavirus, in treating patients with severe pneumonia, Roche said in a statement.

Testing in the trial was composed of two patient groups with severe cases of COVID-19 - one group was given remdesivir and the other a placebo, a fluid that resembles remdesivir but does not offer any of its physiological benefits.

On Friday, South Korean health authorities said they would request imports of remdesivir to treat COVID-19, as new outbreaks of the disease flare after social distancing restrictions were eased.

Gilead's patent gives the USA company exclusive rights to make the antiviral.

Remdesivir is not yet licensed or approved anywhere globally and has not yet been demonstrated to be safe or effective for the treatment of COVID-19. The drug has been authorized for emergency use in the United States. "It will take a final decision based on the recommendations of the expert committee", a source said. Additionally, the drug was found to increase survival, as the group receiving remdesivir had a mortality rate of 8 percent while the group receiving placebo had a rate of 11.6 percent.

Dr. Anthony Fauci, NIAID director and the USA government's top infectious disease expert, also sees promise in the results of the clinical trial.

The global push to develop coronavirus treatments and vaccines is speeding up as governments search for ways to ease lockdowns safely and resume financial activities to restart economies.

Last month, Gilead said it will work with global partners to expand production of remdesivir.

Other reports by Click Lancashire

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