NewsWorldEMA begins review of anti-COVID-19 pill molnupiravir for early use prior to...

EMA begins review of anti-COVID-19 pill molnupiravir for early use prior to final authorisation

The European Medicines Agency announced that it will begin reviewing available data on the use of oral antiviral medicine molnupiravir, produced by US company MSD (Merck Sharp & Dohme), against COVID-19, in order to support national authorities who may decide to use this medicine before it receives final authorisation.

In a statement, EMA and the Heads of of Medicines Agencies (HMA) of the EU’s member states announced that they have agreed on the need for additional guidance on COVID-19 treatments in light of rising rates of infection and deaths due to COVID-19 across the EU.

To this end, EMA is reviewing available data on the use of molnupiravir (also known as MK 4482 or Lagevrio) to support national authorities who may decide on the use of this medicine for COVID-19 treatment prior to its authorisation.

While the more comprehensive rolling review is ongoing ahead of a possible application for a marketing authorisation, EMA’s Committee for Medicinal Products for Human Use (CHMP) will provide EU-wide recommendations in the shortest possible time frame to help national authorities decide on possible early use of the medicine, for example, in emergency use settings.

Molnupiravir is an oral antiviral medicine developed by US company Merck (known as MSD in the EU) in collaboration with Ridgeback Biotherapeutics.

Molnupiravir reduces the ability of SARS CoV 2 (the virus that causes COVID-19) to multiply in the body. It does this by increasing the number of alterations (mutations) in the virus’s genetic material (RNA), in a way that impairs the ability of SARS-CoV-2 to multiply.

EMA and the HMA state that they remain committed to expediting the evaluation of COVID-19 treatments and vaccines, while ensuring these meet the EU’s standards of safety and efficacy. EMA will communicate on the outcome of this review and that of the rolling review once they are concluded.

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