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EU Crunch Time For Myriad Drugs Marks A Busy May Meeting For CHMP

 
• By Neena Brizmohun

The latest meeting of the European Medicines Agency’s human medicines committee, the CHMP, is taking place this week. Decisions are expected for 13 drug marketing applications, there will be a number of oral explanation meetings, and activity is expected relating to a drug at the center of a case involving the European Commission’s rejection of an EMA recommendation.

gene therapy pills
Another hemophilia B gene therapy could be approved in the EU soon • Source: Shutterstock

The European Medicines Agency is this week due to decide whether to recommend in favor of pan-EU marketing authorization for fidanacogene elaparvovec, Pfizer/Spark Therapeutics’ gene therapy for hemophilia B that was approved in the US and Canada this year as Beqvez.

KEY TAKEAWAYS

  • Thirteen new drugs are up for an opinion this week from the European Medicines Agency’s committee, the CHMP, as to whether or not they should be approved for marketing across the EU.

  • They comprise: apadamtase alfa, dasiglucagon, sugemalimab, fidanacogene elaparvovec, a chikungunya vaccine, an influenza vaccine, a germanium (68Ge) chloride/dallium (68Ga) chloride radiopharmaceutical, paclitaxel, bevacizumab, dasatinib and three pomalidomide products.

  • The MAA for one drug has been withdrawn: omecamtiv mecarbil

Fidanacogene elaparvovec is among 13 drugs for which marketing authorization applications (MAA) are listed as being up for an opinion on the 

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