Roche Initiates Phase III Trial in COVID-19 Pneumonia

Daniel Fowler
May 31, 2020

Governments are racing to bolster supplies of remdesivir, which US regulators greenlighted this month as a treatment for the novel coronavirus.

Remdesivir has been granted emergency use authorisation (EUA) by the US Food and Ddrug Administration (FDA) and authorities in Japan to treat hospitalised patients with severe Covid-19.

Financed by remdesivir's maker, Gilead Sciences, the study included about 400 COVID-19 patients who were hospitalized but not on a ventilator in 55 hospitals around the world, including the Brigham in Boston and Miriam Hospital in Providence.

The announcement comes two weeks after the EMA head told the European Parliament it may give an initial green light for sale of remdesivir as a COVID-19 treatment, fast-tracking the drug to market amid tight global competition for resources.

"The good news is that when remdesivir is halted those liver function tests typically go back to normal", she said.

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The companies plan to begin enrolling as many as 450 patients in the U.S., Canada and Europe in June for the trial, called Remdacta. The drug has been authorized for emergency use in the United States.

The final decision will be taken by the drug regulator on the recommendations of the committee. 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.

Roche is also studying Actemra, originally developed for arthritis but also used to control immune reactions in some cancer patients, as a monotherapy in a separate trial of 450 patients due to complete enrolment soon and produce results later this year. Since an increase in blood clots has already been reported in COVID-19 patients, researchers will carefully monitor the 600-700 patients who will be recruited for the second phase.

"As more information about COVID-19 pneumonia becomes available in these unprecedented times, it is more important than ever to work together to fight this disease", said Levi Garraway, Roche's chief medical officer and head of Global Product Development. All new drugs have to undergo trials before getting approval for marketing them in India.

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