Shots:
- The EMA has received MAA of tanruprubart for the treatment of Guillain-Barré syndrome (GBS)
- The MAA dossier demonstrated rapid neuroinflammation control & improved recovery, supported by a PoC study & a P-III trial against PBO, favorable risk/benefit, robust US & Southeast Asian biomarker data, PK (US/EU/SE Asia), & RWE matching P-III outcomes to IVIg or plasma exchange–treated western GBS pts from a 2,000-patient study
- Tanruprubart is being evaluated in the ongoing open-label FORWARD study in the US & EU to support use in pediatric & adult population & across geographies, which will support US FDA’s BLA submission planned for 2026
Ref: Annexon | Image: Annexon | Press Release
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