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EU CHMP Finalizes Outstanding Issues On Aimovig And Symproic

 
• By Maureen Kenny

EU regulators meeting in London are finalizing the outstanding questions they have for companies whose products are approaching the final stages of the approval process.

boexes marked with green check marks
A number of products are nearing the final stage of the EMA review process

The sponsors of 11 products at the later stages of evaluation at the European Medicines Agency are finding out this week what remaining concerns the agency has with their marketing authorization applications (MAAs). The products include Aimovig (erenumab), a potential new migraine treatment from Amgen/Novartis, Shionogi/Purdue Pharma’s Symproic (naldemedine) for opioid-induced constipation (OIC) in adults, and Dsuvia (sufentanil) from AcelRx Pharmaceuticals for the management of acute moderate to severe pain.

The 11 products also include three biosimilar versions of AbbVie Inc.'s Humira (adalimumab) and one biosimilar of Johnson & Johnson's Remicade (infliximab).

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