Health Canada accepts rolling submission for Merck’s experimental COVID therapy

pharmafile | August 16, 2021 | News story | Sales and Marketing  

Merck has begun its rolling submission to Health Canada for its experimental antiviral agent, molnupiravir, as a potential COVID-19 therapy.

Molnupiravir is being developed by Merck in partnership with Ridgeback Biotherapeutics, and is an oral formulation of a potent ribonucleoside analogue with antiviral activity against the SARS-CoV-2 virus.

The rolling submission was accepted by Health Canada under the Interim Order of the Minister of Health, which permits the review of initial safety, quality, and efficacy findings while late-stage studies are underway.

When available, results from the molnupiravir development programme, will be submitted to Health Canada and a decision will following the review of all required evidence.

The antiviral agent was invented by Emory University’s not-for-profit biotechnology company, Drug Innovations at Emory.

In March this year, Merck and Ridgeback reported preliminary results from a Phase IIa trial of molnupiravir for Covid-19 and a Phase II/III trial is underway.

The randomised, placebo-controlled, double-blind, multi-centre MOVe-OUT trial is analysing oral doses of the drug in 1,850 non-hospitalised Covid-19 patients aged 18 years or above.

In various preclinical models, including for prophylaxis, treatment and prevention, molnupiravir had demonstrated activity against SARS-CoV-2. The drug was also observed to be active in SARS-CoV-1 and MERS models.

Kat Jenkins

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