EMA issues advice on Merck’s antiviral treatment for COVID-19

Nov. 22, 2021

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has issued advice on the use of an antiviral COVID-19 medication from Merck.

The medication is Lagevrio, which is known by molnupiravir or MK 4482 in the United States. Merck developed the medication in conjunction with Ridgeback Biotherapeutics.

The agency said its advice can now be used to support national recommendations on the possible emergency use of the medicine before EMA makes a wider recommendation for the use of the drug.

Separately, EMA also said it is reviewing evidence to support another COVID-19 antiviral treatment from Pfizer, called PAXLOVID (PF-07321332/ritonavir).  

In the United States, the U.S. Food and Drug Administration (FDA) also is reviewing requests for emergency use authorization for both medications.

The medicine from Merck can be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of developing severe COVID-19, the EMA said. The medicine should be administered as soon as possible after diagnosis of COVID-19 and within 5 days of the start of symptoms. The medicine, which is available as capsules, should be taken twice a day for 5 days.

The advice follows a review of data, including data on the medicine’s quality and results from completed and ongoing studies. Interim results from the main study in non-hospitalized, unvaccinated patients with at least one underlying condition putting them at risk of severe COVID-19 were assessed as part of this advice. Lagevrio, when given at a dose of 800 mg twice a day, reduced the risk of hospitalization and death when treatment started within 5 days of the start of symptoms.

About one month after treatment started, 7.3% of patients (28 out of 385) who took Lagevrio compared with 14.1% (53 out of 377) of patients who took placebo (a dummy treatment) had been hospitalized or had died; none of the patients in the Lagevrio group died compared with eight patients in the placebo group.

Lagevrio is not recommended during pregnancy and in women who can become pregnant and are not using effective contraception. Women who can become pregnant must use effective contraception during treatment and for 4 days after the last dose of Lagevrio. Breastfeeding should be interrupted during treatment and for 4 days after treatment.

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