Evobrutinib
- Generic Name
- Evobrutinib
- Drug Type
- Small Molecule
- Chemical Formula
- C25H27N5O2
- CAS Number
- 1415823-73-2
- Unique Ingredient Identifier
- ZA45457L1K
- Background
Evobrutinib is under investigation in clinical trial NCT03934502 (Effect of Meal Composition and Timing on Evobrutinib Bioavailability).
Merck KGaA in Advanced Talks to Acquire SpringWorks Therapeutics; BridgeBio Secures EU Approval for ATTR Drug
• Merck KGaA confirms advanced acquisition discussions with SpringWorks Therapeutics, though critical conditions remain unmet and no binding agreement has been reached.
• BridgeBio Pharma's Beyonttra (acoramidis) receives European Commission approval for transthyretin amyloidosis with cardiomyopathy, triggering a $75 million milestone payment from Bayer.
• Biohaven's troriluzole receives FDA priority review for spinocerebellar ataxia, positioning it to potentially become the first approved treatment for this neurodegenerative disorder.
Tolebrutinib Receives FDA Breakthrough Therapy Designation for Non-Relapsing Secondary Progressive Multiple Sclerosis
• The FDA has granted Breakthrough Therapy designation to tolebrutinib for adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS).
• The designation is based on positive results from the HERCULES phase 3 study, which demonstrated a 31% delay in disability progression compared to placebo.
• Tolebrutinib is the first brain-penetrant BTK inhibitor to receive this designation for MS, addressing a critical unmet need in delaying disability progression.
• Regulatory submissions for tolebrutinib are being finalized in the US and EU, with ongoing studies for primary progressive MS anticipated in H2 2025.
Multiple Sclerosis Research Update: Advances in Understanding and Treatment
• Genetic risk factors for MS were traced back to migrations 5,000 years ago, offering insights into disease origins.
• An autoantibody signature was identified in some MS patients years before symptom onset, potentially aiding early diagnosis.
• Tolebrutinib showed promise in slowing disability progression in non-relapsing secondary progressive MS, a first for this condition.
• Research suggests starting high-efficacy DMTs early in pediatric MS reduces relapse risk and long-term disability.
Systematic Review of Phase II and III Clinical Trials for Relapsing Multiple Sclerosis
A comprehensive systematic review of phase II and III clinical trials for relapsing multiple sclerosis (RMS) has been conducted, focusing on trial designs and primary endpoints. The review, which analyzed 60 trials from three major trial registration systems, highlights the dominance of randomized controlled parallel-arms trials and discusses the most common primary endpoints across different trial phases and patient groups. The findings suggest a need for revisions in regulatory guidelines and expert recommendations to better align with current clinical trial practices.
Drug Development Updates
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