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The pivotal ConfIdeS study has finished enrollment and is now with the FDA. IdeS is imlifidase, with the brand name Idefirix. It has been conditionally approved by EMA and is on the market in Europe since 2020. Idefirix is a niche product, an orphan drug. It is a cysteine protease Continue reading Idefirix PDUFA Date and the IdeS of March
Hansa is a small Swedish company with a unique product, a protease from Strep. pyogenes that cleaves IgG called Imlifidase, Idefirix or IdeS for short. They steered IdeS through a difficult early development, obtained approval for their drug in many EU countries for ‘desensitisation treatment of highly sensitised adult kidney transplant Continue reading HANSA, Where is the Beef?