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Merck seeks first US regulator’s authorisation for Covid-19 tablet

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Pharmaceutical company Merck said today (October 11) it has applied for US emergency use authorisation for its tablet to treat mild-to-moderate patients of Covid19, putting it on course to become the first oral antiviral medication for the disease.

Its authorisation could help change clinical management of Covid19 as the pill can be taken at home. The treatment, molnupiravir, could halve the chances of death or being hospitalised for those most at risk of contracting severe Covid19, according to the drugmaker.

The interim efficacy data on the drug, which has been developed with Ridgeback Biotherapeutics, had heavily impacted the shares of Covid19 vaccine makers when it was released last week.

Existing drugs from Gilead Sciences Inc’s infused antiviral remdesivir and generic steroid dexamethasone are generally given only once a patient is hospitalized.

Monoclonal antibody drugs from Regeneron Pharmaceuticals Inc and Eli Lilly have so far seen only limited use due to the difficulty in administering them.

No significant efficacy

In India, however, two drugmakers had last week sought to end late-stage trials of their generic versions of molnupiravir to treat moderate Covid19, according to study documents.

A source with the Drug Controller General of India had said the pill has not shown “significant efficacy” against moderate cases, but was successful against mild cases.

Merck said its trials are based on U.S. Food and Drug Administration definitions, which for moderate Covid19 describe blood oxygen levels as no lower than 93 per cent whereas the trials in India define moderate as blood oxygen levels between 90 and 93 per cent.

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