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Tuesday, December 7, 2021

EMA could start reviewing Merck Covid-19 pill within days

The European Medicines Agency (EMA) could start reviewing the US-manufactured Merck Covid-19 pill within days, according to a senior official.

Merck’s new Covid-19 pill ‘molnupiravir’ was shown to reduce hospitalisations by 50% and brings relief to many people who were hoping that a simple pill would be enough to treat the virus.


Head of vaccine strategy at the EMA Marco Cavaleri told journalists, “What I can say is that indeed we will be considering whether to start a rolling review for this compound in the next days,”.

He added that the agency was aware of some “top-line results” that are being communicated by the pharmaceutical company about the new drug.

The US firm announced on Friday that it plans to submit an application to the US FDA and other regulatory bodies around the world for the drug.


The company’s trial results revealed that there were no reported deaths among the 770 patients who received the drug while eight deaths were reported in the placebo group.

Drug approvals can be sped up by the EMA by examining safety and efficacy data as they’re released, instead of waiting until after a formal application for authorisation is filed by the manufacturer.

Hailed as a possible breakthrough for the virus, the Merck pill differs from other Covid-19 therapeutics, as the majority of them can only be administered intravenously.


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