EU Crunch Time For Previously Rejected Lagevrio & Other New Drugs

MSD/Ridgeback Biotherapeutics’ COVID-19 treatment Lagevrio is among the products that are up for an opinion this week from the European Medicines Agency on whether they should be recommended for use across the EU.

Decisions are due on whether or not several new drugs should be approved for use in the EU • Source: Shutterstock

The European Medicines Agency could this week decide whether to reverse the opinion it adopted in February recommending against pan-EU marketing approval for MSD/Ridgeback Biotherapeutics’ COVID-19 treatment, Lagevrio (molnupiravir).

Key Takeaways
  • The latest monthly meeting of the European Medicines Agency’s human medicines committee, the CHMP, is taking place on 19-22 June.
  • New drugs listed on the meeting's draft agenda as being up for an opinion by the CHMP on whether they should be granted pan-EU marketing approval include Amylyx Pharmaceuticals’ sodium phenylbutyrate/ursodoxicoltaurine, AbbVie’s atogepant, GSK’s daprodustat and the generic or hybrid drug enalapril maleate.
  • A decision on whether the EMA will overturn its rejection of MSD/Ridgeback Biotherapeutics’ COVID-19 treatment, Lagevrio, is also expected

MSD was today due to present at an oral explanation meeting before the EMA’s human medicines committee, the CHMP, to make its case for approving the drug, according to the

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