Novartis’s Remibrutinib Succeeds In Pivotal CSU Trials With Promise Of Liver Safety

 
• By Ayisha Sharma

The major’s BTK inhibitor candidate, remibrutinib, met the primary and secondary endpoints of two Phase III trials in chronic spontaneous urticaria, with unproblematic liver function results so far, suggesting it may avoid pitfalls faced by rivals.  

drawn outline of a liver on a blue background, post it with smiley face
Liver Toxicities Have Plagued Other BTK Inhibitors For Multiple Sclerosis • Source: Shutterstock
Key Takeaways:

  • The REMIX-1 and REMIX-2 trials saw clinically meaningful results in the disease activity score primary endpoint.

  • Liver function test results were similar across both the treatment and placebo arms.

  • Detailed data will be presented at an upcoming medical meeting and Novartis will file the drug in CSU next year.

Novartis AG’ remibrutinib has hit its endpoints in a pair of late-stage studies in chronic spontaneous urticaria (CSU) patients uncontrolled on standard-of-care, but analysts expressed a desire

CSU affects around 40 million people worldwide and is characterized by chronic hives on the body that last for at least six weeks

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