Novartis Reports Positive Phase 3 Results for Remibrutinib in Multiple Sclerosis
核心洞察
Novartis announced that a Phase 3 trial of its oral multiple sclerosis (搜索) drug remibrutinib met its primary endpoint, significantly reducing relapses compared with teriflunomide.
Remibrutinib also outperformed teriflunomide on all key secondary endpoints while demonstrating a favorable and stable safety profile.
The results address an unmet need for oral therapies offering robust relapse prevention and slower disability progression, according to Novartis Chief Medical Officer Shreeram Aradhye.
Novartis reported encouraging results from a Phase 3 clinical trial of its investigational oral therapy remibrutinib for the treatment of multiple sclerosis (搜索) (MS), sending U.S.-listed shares of the Swiss drugmaker up roughly 6% in recent trading. The company said the drug helped lower relapse rates and reduced adverse effects at a higher rate than a rival treatment, meeting the trial's primary endpoint.
The trial compared remibrutinib with teriflunomide, a therapy originally developed by French pharmaceutical company Sanofi through its subsidiary Genzyme Corporation. The patent on teriflunomide has since expired, and the drug is now produced by several generic manufacturers. According to Bloomberg News, Novartis' drug significantly reduced relapses among patients compared with teriflunomide, and remibrutinib also outperformed teriflunomide on all key secondary endpoints.
Novartis highlighted the drug's favorable and stable safety profile. "Despite advances in treatment, an unmet need remains for oral therapies that can deliver robust relapse prevention, slow disability progression, while maintaining a favorable safety profile," Novartis Chief Medical Officer Shreeram Aradhye said in a release.
The results could bolster investor confidence in Novartis' drug pipeline. Remibrutinib has already been approved to treat chronic spontaneous urticaria (搜索), a disorder that causes recurring hives, and is also being evaluated as a potential treatment for other skin and allergy conditions.
Novartis said it plans to present the trial data at an MS conference in Toronto in October. On the Zurich Stock Exchange, the stock was up 4.7% in early trading at CHF 129.04. With Tuesday's gains, Novartis shares are up 17% since the start of the year, though they remain about 6% off their February highs.