Shots:
- The US FDA has approved Rhapsido for the treatment of adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Regulatory filings are also made in the EU, Japan & China, with priority review granted in China
- Approval was backed by P-III (REMIX-1 & 2) trials in CSU, which showed improved itch, hives, & weekly urticaria activity by Wk.12, with more pts achieving well-controlled disease as early as Wk.2 & at Wk.12, while ~33.3% reached complete absence of itch & hives by Wk. 12
- Rhapsido (PO, BD) blocks BTK to inhibit the release of histamine & other proinflammatory mediators for CSU treatment, plus it is being evaluated across multiple trials for CIndU, hidradenitis suppurativa, & food allergy
Ref: Novartis | Image: Novartis | Press Release
Related News:- Monte Rosa Therapeutics Enters a ~$5.7B with Novartis to Develop Degraders for Immune-Mediated Diseases
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