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First oral antiviral drug for COVID-19 reviewed by Health Canada

Early phase 2/3 data including early safety, quality and efficacy data for Merck’s molnupiravir will be reviewed by the regulator while the study is still underway


Hopes for an effective oral antiviral drug against SARS-CoV-2 have been raised after Merck & Co announced that Health Canada will perform a rolling review of data of its drug, molnupiravir.

The phase 2/3 MOVe-OUT trial will see 1,850 people who have confirmed COVID-19 and at least one risk factor associated with poor disease outcome randomised to receive the drug or placebo. The twice-daily pill will be given for five days in the study, which will look at the percentage of participants who are hospitalised and/or die within 28 days.

The rolling submission process was accepted under the Minister of Health’s Interim Order number 2, which allows for the review of early safety, quality and efficacy data while later-stage clinical trials take place. Merck will share its findings from the clinical programme as they become available but Health Canada will make a decision only when all necessary evidence has been submitted and reviewed.

An oral antiviral drug is seen by many as an essential part of an effective medical toolkit against COVID-19. At present, Gilead’s Veklury (remdesivir) is being used to treat COVID-19 but only for people with more severe disease in hospital as it needs to be administered intravenously.

Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics, although the drug was originally discovered at Drug Innovations at Emory (DRIVE), a non-profit biotech wholly owned by Emory University, a private research university based in Atlanta, Georgia.

In July, phase 2 interim results were presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). Molnupiravir is a potent ribonucleoside analog with antiviral activity against SARS-CoV-2 – prophylaxis, treatment and prevention of transmission – and SARS-CoV-1 (the virus that caused the 2003 SARS outbreak) and MERS.

With MOVe-OUT expected to deliver results in September or October, the hope is that molnupiravir will be available to treat less severe non-hospitalised patients before the end of the year.

In June, Merck signed an agreement with the US government to supply about 1.7 million courses of molnupiravir in a deal worth about $1.2bn. The company estimates it could have 10 million courses of the antiviral available by the end of 2021.

Merck has also signed voluntary licensing agreements with five Indian generic drug manufacturers to expand access to molnupiravir, and non-exclusive voluntary licensing agreements with other generic manufactures to offer the drug in 104 low- and middle-income countries.

Article by
Hugh Gosling

17th August 2021

From: Research



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