Why The EMA Said No To Kizfizo And Cinainu

The European Medicines Agency has recommended against EU marketing approval for two drugs targeting children.

Hand push red Red Cross mark to choose cancellation item , Approve and reject business and document
The EMA has recommended against approving two new drugs (Shutterstock)

The European Medicines Agency said on 15 November that pan-EU marketing authorizations should be refused for Kizfizo (temozolomide) and Cinainu (allium/citrus/paullinia/cacao), which are two treatments for use in children from Orphelia Pharma and Legacy Healthcare respectively.

Key Takeaways
  • The European Medicines Agency this week recommended against pan EU marketing authorization for two drugs – Kizfizo and Cinainu, from Orphelia Pharma and Legacy Healthcare respectively.
  • Orphelia and Legacy will be able to ask the EMA to re-examine its decisions

The EMA recommended against approving Kizfizo for treating children with neuroblastoma, saying it was not possible to

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