EMA considers rolling review of first anti-Covid pill ‘in coming days’

EMA considers rolling review of first anti-Covid pill ‘in coming days’
Credit: Merck

Within the next few days, the European Medicines Agency (EMA) could start reviewing Molnupiravir, the pill against the coronavirus developed by Merck and Ridgeback Biotherapeutics, EMA announced on Tuesday.

A ‘rolling review’ of the drug is being considered “in the coming days,” the EMA’s chief vaccine strategist, Marco Cavaleri, told reporters. This way, the EMA will pave the way for a possible authorisation of the pill in the European Union.

Such a review will allow the EMA to assess the safety and efficacy data as soon as it comes in. This means that it is not necessary to wait for a formal application by the manufacturer, aiming to speed up the assessment of an application when it is actually submitted.

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At the end of last week, Merck and Ridgeback Biotherapeutics announced that a clinical trial showed that the drug halved the risk of hospitalisation and death from Covid-19.

The pill would be a major advance in the fight against the pandemic, says Merck, which announced that it plans to submit Molnupiravir for emergency use authorisation (EUA) to the American medicines agency FDA in the hope that it will be approved for use as soon as possible.

In the meantime, the company has already started production of the pill, and expects to produce enough pills to treat 10 million patients by the end of this year, with more expected to be produced in 2022.

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