Teriflunomide
- Generic Name
- Teriflunomide
- Brand Names
- Aubagio, Teriflunomide Accord, Teriflunomide Mylan
- Drug Type
- Small Molecule
- Chemical Formula
- C12H9F3N2O2
- CAS Number
- 163451-81-8
- Unique Ingredient Identifier
- 1C058IKG3B
- Background
Teriflunomide is the active metabolite of leflunomide, and it acts as an immunomodulatory agent by inhibiting pyrimidine synthesis. It is marketed under the name Aubagio® and is indicated for the treatment of multiple sclerosis, specifically relapsing forms. The FDA label states an important warning about the risk of hepatoxicity and teratogenicity for patients using teriflunomide.
- Indication
Used in the treatment of relapsing forms of multiple sclerosis (MS).
- Associated Conditions
- Multiple Sclerosis
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.
Sanofi's Q3 Sales Surge 15.7% Driven by Vaccines and Dupixent; 2024 EPS Guidance Raised
• Sanofi reported a robust 15.7% sales growth in Q3, fueled by strong vaccine sales and the continued success of Dupixent, with sales up 23.8% to €3,476 million.
• Pharma launches, including ALTUVIIIO, Nexviazyme, and Rezurock, saw a significant 67.1% increase, contributing €727 million to the overall sales growth.
• The company's pipeline advanced with four regulatory approvals, including Dupixent for COPD in the US and China, and four positive Phase 3 data readouts, including tolebrutinib for nrSPMS.
• Based on strong Q3 business performance, Sanofi has raised its 2024 business EPS guidance to at least a low single-digit percentage growth at CER.
Sanofi's Tolebrutinib Shows Promise in Non-Relapsing Secondary Progressive MS
• Tolebrutinib demonstrated a 31% reduction in the time to onset of confirmed disability progression in patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS).
• A nearly two-fold increase in confirmed disability improvement was observed with tolebrutinib compared to placebo, suggesting potential for disease modification.
• Sanofi plans to submit tolebrutinib for global regulatory approvals in the second half of 2024, marking a significant step towards addressing unmet needs in nrSPMS.
• While showing promise in nrSPMS, tolebrutinib failed to meet primary endpoints in relapsing MS trials, highlighting the drug's specific efficacy profile.
Kesimpta Demonstrates Sustained Efficacy in Relapsing Multiple Sclerosis
• Kesimpta (ofatumumab) shows promise in reducing disability progression and disease activity in patients with relapsing multiple sclerosis (RMS) based on ALITHIOS and OLIKOS trial data.
• Treatment-naïve RMS patients on continuous Kesimpta were more likely to avoid six-month confirmed disability worsening compared to those switching from Aubagio (83.4% vs. 76.3%).
• The OLIKOS trial found no new gadolinium-enhancing T1 lesions at 12 months in clinically stable RMS patients switching from IV anti-CD20 therapy to Kesimpta.
• Continuous Kesimpta led to fewer disability worsening events and a greater likelihood of being progression-free, especially when initiated early in the disease course.
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• Inavolisib (Itovebi) receives FDA approval when combined with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer.
• The approvals offer new treatment options for a broader range of breast cancer patients, addressing unmet needs and improving care approaches.
Tolebrutinib Shows Promise in Slowing Disability Progression in Non-Relapsing Secondary Progressive MS
• Tolebrutinib significantly delayed the onset of 6-month confirmed disability progression by 31% compared to placebo in patients with nrSPMS.
• The proportion of patients experiencing confirmed disability improvement nearly doubled with tolebrutinib compared to placebo, indicating potential for functional gains.
• Safety data showed liver enzyme elevations as a notable adverse event, but most cases resolved without intervention, emphasizing the need for careful monitoring.
• HERCULES trial results support tolebrutinib as a potential treatment for nrSPMS, addressing a significant unmet need in managing disability accumulation.
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