Canadian Manufacturing

Merck Canada initiates rolling submission to Health Canada for COVID-19 antiviral pill

The rolling submission process was accepted under the Minister of Health's Interim Order, which allows for the review of early safety, quality and efficacy data.

August 16, 2021  by CM Staff

Investigational antiviral pill molnupiravir (image not actual size) (2020) (CNW Group/Merck Canada Inc.)

KIRKLAND — On Aug. 16, Merck, known as MSD outside the United States and Canada, announced the initiation of a rolling submission to Health Canada for molnupiravir, an investigational twice daily oral antiviral agent currently in trials as a potential treatment for COVID-19. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics.

The rolling submission process was accepted under the Minister of Health’s Interim Order, which allows for the review of early safety, quality and efficacy data while later-stage clinical trials take place. Further findings from the ongoing molnupiravir development program will be shared with Health Canada as they become available. Health Canada will make a decision only when all necessary evidence has been submitted and reviewed.

Phase 2 interim results from the Phase 2/3 MOVe-OUT clinical trials were presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in July. Phase 3 of the trial, evaluating molnupiravir twice daily for five days in non-hospitalized adults with confirmed SARS-CoV-2, five days or less following symptom onset and at least one risk factor associated with poor disease outcomes, is underway and includes sites in Canada.

MOVe-OUT (MK-4482-002) is a Phase 2/3, randomized, placebo-controlled, double-blind, multi-site study evaluating orally administered molnupiravir in non-hospitalized participants at least 18 years of age with laboratory confirmed COVID-19 and symptom onset within five days prior to randomization. The trial plans to enroll a total of 1,850 participants with mild or moderate COVID-19. A total of 1,550 patients in the Phase 3 portion of the trial will be randomized 1:1 to receive either molnupiravir (800 mg) or placebo twice daily for five days.

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In Canada, Merck markets a broad range of vaccines, pharmaceutical and animal health products and is an R&D investor in Canada, with investments totaling $93.58 million in 2020 and more than $1.3 billion since 2000.