Shots:
- The CHMP has recommended approval of remibrutinib for CSU in adults with inadequate response to H1-antihistamines, with a final decision from the EC expected within ~2 mos.
- Opinion was supported by the global P-III REMIX-1 & 2 trials in 925 pts uncontrolled on second-generation H1-antihistamines, where remibrutinib showed superiority vs PBO in ISS7, HSS7 & UAS7 at Wk 12, with itch and hive improvement from Wk 1 sustained to Wk 52, along with QoL and sleep benefits and a favorable safety profile without liver concerns
- Remibrutinib is a highly selective oral BTK inhibitor that blocks the BTK pathway responsible for histamine release, helping reduce itching, hives, and swelling associated with CSU
Ref: Novartis | Image: Novartis | Press Release
Related News: Novartis AG to Transfer Stake in Novartis India Limited to ChrysCapital
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
