Regulatory Phase 3 Approval of Novartis' BTK Inhibitor Raises Concerns...

Phase 3 Approval of Novartis’ BTK Inhibitor Raises Concerns about Dupixent’s Risks


Novartis is effectively navigating the competition to retain its foothold in the chronic hives market. Despite increasing rivalry targeting its popular drug Xolair, the Swiss pharmaceutical company has unveiled positive top-line outcomes from two phase 3 clinical trials. These promising results are expected to support upcoming applications for regulatory approval in the coming year.

Currently, Novartis, in partnership with Roche, has positioned Xolair as the primary therapeutic choice for patients contending with chronic spontaneous urticaria (CSU) – an enduring form of hives that persists even after using drugs like antihistamines. However, the market landscape is on the brink of significant transformation. Sanofi and Regeneron’s Dupixent are predicted to secure approval for this indication this year, and the introduction of Xolair biosimilars further contributes to the evolving market dynamics.

In response to these imminent challenges, Novartis has identified the oral BTK inhibitor remibrutinib as a potential solution to safeguard its standing in this evolving landscape. Recent top-line data from phase 3 trials strongly reinforce Novartis’ confidence in the potential of remibrutinib.

In the two phase 3 clinical trials conducted by Novartis, participants suffering from CSU experienced substantial improvements in their weekly urticaria activity scores after 12 weeks of twice-daily oral dosing. This measurement, which assesses the severity of hives and itching, showed significant changes from the baseline. Particularly, patients who had insufficient symptom control with H1-antihistamines observed significant enhancements, leading both trials to successfully meet their primary endpoints. Impressively, symptom relief was evident within a mere two weeks.

Shreeram Aradhye, Chief Medical Officer at Novartis, emphasized the urgent need for effective, convenient, and well-tolerated treatments that can address the substantial impact of chronic hives on patients’ daily lives. He highlighted remibrutinib’s potential as a groundbreaking oral treatment that could fulfill these requirements.

Significantly, these phase 3 trial results contribute to the growing body of evidence suggesting that remibrutinib might not carry the liver toxicity issues associated with other BTK inhibitors. Novartis stressed that the drug demonstrated a favorable safety profile and was well-tolerated, with balanced liver function tests across both active and placebo groups in the trials. This sets remibrutinib apart from other BTK inhibitors under development by Merck KGaA and Sanofi, which have been linked to liver injuries in different therapeutic contexts.

While detailed data from the phase 3 trials have not yet been shared by Novartis, the positive top-line results, combined with mid-phase findings, indicate that remibrutinib could potentially offer comparable efficacy to its biologic competitors in an easily manageable oral form. The company is continuing the trials to reach their final 52-week conclusions, with plans to seek regulatory approval in the next year.

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