EMA supports molnupiravir prior to formal authorisation

The European Medicines Agency (EMA) has issued emergency use advice (EUA) supporting a decision by national authorities for the possible early use of Merck's molnupiravir, the oral antiviral drug for the treatment of patients with COVID-19.

The EU regulator has not yet formally authorised the drug.

The EMA advised that the experimental drug can be used to treat adults with the virus who do not require supplemental oxygen and are at a higher risk of developing severe COVID-19.

The EMA stated that it offered the advice ‘to support national authorities who may decide on a possible early use of the medicine prior to marketing authorisation, for example in emergency use settings, in light of rising rates of infection and deaths due to COVID-19 across the EU’.

Data from clinical trials suggests that the drug, given at a dose of 800mg twice a day, reduced the risk of hospitalisation and death when treatment started within five days of the onset of symptoms.

The most common side effects of the treatment included diarrhoea, nausea, dizziness and headaches. All of these were reported as either mild or moderate.

The recent advice issued by the EMA states that molnupiravir should be administered as soon as possible following a positive diagnosis for SARS-CoV-2.

Clinical trial data revealed that 7.3% of patients taking the antiviral drug were hospitalised or died due to COVID-19 related complications, compared to 14.1% taking a placebo. None of the patients taking molnupiravir, also known as Lagevrio, died from COVID-19-related causes, compared with eight patients in the placebo group.

The UK became the first nation to approve Merck’s COVID-19 drug in November. It is hoped that the antiviral oral drug will minimise symptoms and accelerate recovery, thereby reducing the burden on hospitals in anticipation of the winter and assisting in the management of the pandemic in poorer nations with reduced healthcare services.