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August 16, 2021

Coronavirus company news summary – Merck begins molnupiravir rolling submission to Health Canada – FDA rejects Rigel’s fostamatinib for Covid-19 treatment, seeks more data

By Chris Lo

Merck has started a rolling submission to Health Canada for its antiviral agent, molnupiravir, for the potential treatment of Covid-19. The agency accepted the rolling submission process under the interim order of the Minister of Health, enabling the review of initial safety, quality and efficacy data. Results from the ongoing late-stage studies will be submitted to Health Canada upon availability. The agency will make a regulatory decision after reviewing all the required data.

The US Food and Drug Administration has declined to authorise Rigel Pharmaceuticals’ fostamatinib for emergency use to treat Covid-19 in hospitalised patients, stating that the results from the drug’s 59-patient NIH/NHLBI-sponsored Phase II clinical trial are not sufficient. Rigel intends to again seek authorisation from the regulator if its ongoing 308-patient Phase III trial of fostamatinib in hospitalised Covid-19 patients meets its endpoint of reducing the proportion of patients who progress to severe or critical disease within 29 days.

Moderna has signed an agreement to supply more doses of its vaccine to the Government of Canada during 2022 and 2023, with an option to extend into 2024. The agreement is for 40 million doses, with up to another 65 million if all options are exercised. Depending on how the epidemiological situation evolves in the country, Moderna will provide access to new adapted Covid-19 vaccines to address viral variants.

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