EMA Issues Advice on MSD's COVID-19 Drug

Dawn O'Shea

November 24, 2021

The European Medicines Agency (EMA) has issued guidance on the use of Lagevrio (molnupiravir/MK 4482) for the treatment of COVID-19.

The EMA has advised that the medicine, which is currently not authorised in the EU, 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. It should be administered as soon as possible after a diagnosis of COVID-19 and within five days of the onset of symptoms. The medicine, which is available as capsules, should be taken twice a day for five days.

The advice is intended to support national authorities who may decide on the early use of the medicine prior to marketing authorisation, in light of rising rates of infection and deaths due to COVID-19 across the EU.

Clinical trial data suggest Lagevrio at a dose of 800 mg twice daily reduces the risk of hospitalisation and death in non-hospitalised, unvaccinated patients with ≥1 underlying condition. A month after initiation of treatment, 7.3% of patients who took Lagevrio had been hospitalised or died compared with 14.1% of those taking placebo.

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