argenx Reports the US FDA’s Acceptance of sBLA for Vyvgart Hytrulo with Priority Review for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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- The US FDA has accepted and granted priority review to argenx’s sBLA of Vyvgart Hytrulo for treating chronic inflammatory demyelinating polyneuropathy (CIDP) with the decision anticipated on Jun 21, 2024
- The sBLA was based on the data from (ADHERE) trial investigating the safety and efficacy of Vyvgart Hytrulo (SC) vs PBO for treating CIDP adults (n=322)
- The results revealed lower relapse risk by 61%, evidence of clinical improvement in 67% of patients across the trial’s open-label Stage A and the role of IgG autoantibodies in the underlying biology of CIDP based on the drug’s MOA. 226/228 patients progressed in the (ADHERE-+) extension trial after the (ADHERE) study
Ref: argenx | Image: argenx
Related News:- Argenx Reports Results of VYVGART Hytrulo in P-III study for Primary Immune Thrombocytopenia
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
