Sanofi-Aventis U.S. Llc

Tecentriq and Avastin Combination Now Funded for Advanced Liver Cancer in New Zealand

2 months ago

• Pharmac has approved public funding for Tecentriq (atezolizumab) in combination with bevacizumab for hepatocellular carcinoma (HCC) in New Zealand, benefiting approximately 70 patients diagnosed annually. • The immunotherapy combination has demonstrated a 34% reduction in risk of death, with half of patients surviving beyond 18 months, representing a significant improvement over previous treatment options. • Māori and Pacific populations are disproportionately affected by HCC due to higher prevalence of risk factors including Hepatitis B and C, with Māori patients 31% more likely to die from liver cancer than non-Māori.

FDA Approves First Rapid-Acting Insulin Biosimilar Merilog for Diabetes Management

3 months ago

• The FDA has granted approval to insulin-aspart-szjj (Merilog), marking the first rapid-acting insulin biosimilar for diabetes treatment, expanding treatment options for over 38 million Americans with diabetes. • Developed by Sanofi-Aventis as a biosimilar to Novo Nordisk's Novolog, Merilog is indicated for glycemic control in both adult and pediatric diabetes patients, available in pre-filled pens and multiple-dose vials. • The approval represents FDA's ongoing commitment to increase access to affordable insulin options, joining two previously approved long-acting insulin biosimilars from 2021.

Tolebrutinib Receives FDA Breakthrough Therapy Designation for Non-Relapsing Secondary Progressive Multiple Sclerosis

5 months ago

• 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.

Propionic Acid Supplementation Shows Promise in Multiple Sclerosis Treatment

6 months ago

• Propionic acid, a short-chain fatty acid produced by gut bacteria, may play a beneficial role in multiple sclerosis (MS) pathology by influencing immune and nervous systems. • Supplementation with propionate demonstrates immunoregulatory, neuroprotective, and neurogenerative effects in MS patients, potentially counteracting the pro-inflammatory state. • Propionic acid could improve outcomes when used with immune-modulating therapy by regulating the immune system and decreasing gut and blood-brain barrier permeability. • Further clinical trials are needed to evaluate the efficacy and safety of propionic acid supplementation in MS patients as a complementary therapeutic strategy.

Advancements in Clinical Trials for Fabry Disease, C. difficile Infections, and Mydriasis

6 months ago

• Clinical trials are actively progressing for Fabry Disease, with companies like Idorsia and Sanofi Genzyme developing novel therapies. • Emerging treatments like Venglustat and Pegunigalsidase alfa are expected to significantly impact the Fabry Disease market in the coming years. • Research and development efforts are also focused on Clostridium Difficile Infections, with Vedanta Biosciences leading Phase 3 trials for VE303. • Mydriasis treatments are advancing, with companies like Eyenovia exploring solutions like MYDCOMBI for pupil dilation.

FDA Approves Zolbetuximab for CLDN18.2-Positive Gastric and GEJ Adenocarcinoma

6 months ago

• The FDA approved zolbetuximab in combination with chemotherapy for HER2-negative, CLDN18.2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma on October 18, 2024. • Approval was based on the SPOTLIGHT and GLOW phase 3 trials, which demonstrated improved progression-free and overall survival with zolbetuximab plus chemotherapy. • Zolbetuximab targets CLDN18.2, a protein overexpressed in 50-80% of gastric cancers, offering a new targeted therapy option for previously non-targetable disease. • Routine CLDN18.2 testing is now crucial to identify patients who can benefit from zolbetuximab, establishing it as a standard of care in the first-line setting.

Isatuximab Combinations Show Promise in Newly Diagnosed Multiple Myeloma

6 months ago

• Isatuximab plus VRd significantly reduced disease progression or death risk by 40.4% in transplant-ineligible newly diagnosed multiple myeloma patients. • The FDA approved isatuximab-irfc with VRd for transplant-ineligible multiple myeloma, based on the IMROZ trial data. • Isatuximab-RVd induction therapy improved progression-free survival in transplant-eligible newly diagnosed multiple myeloma patients, GMMG-HD7 trial showed. • The addition of isatuximab to RVd led to higher rates of minimal residual disease negativity, indicating deeper responses.

Roflumilast Cream Shows High Efficacy in Treating Atopic Dermatitis in Adults and Children

6 months ago

• Roflumilast cream 0.15% demonstrated significantly higher efficacy than the vehicle in achieving a validated IGA-AD score of 0/1 in patients with atopic dermatitis. • The study found that over 95% of patients treated with roflumilast cream reported no signs of application site irritation, highlighting its tolerability. • Roflumilast significantly improved EASI 75 scores compared to the vehicle, indicating a substantial reduction in eczema severity among treated patients. • This once-daily, nonsteroidal cream addresses key unmet needs in atopic dermatitis treatment, potentially improving patient adherence and outcomes.

Nemolizumab Shows Sustained Efficacy in Long-Term Atopic Dermatitis Treatment

8 months ago

• Nemolizumab demonstrates continuous improvement in atopic dermatitis symptoms over 56 weeks, according to interim findings presented at the 2024 EADV Congress. • ARCADIA trial analysis reveals that 47% of patients achieved clear or almost clear skin, a significant increase from the initial 29%. • The study also found that 73% of subjects experienced a 75% improvement in their Eczema Area and Severity Index (EASI) scores. • Nemolizumab's safety profile remains consistent, with no unexpected adverse events or increased risk of infection observed during the trial.

Hemophilia A and B Pipeline Advances with Novel Therapies in Clinical Trials

8 months ago

• Several companies are actively developing novel therapies for Hemophilia A and B, with many in various phases of clinical trials, showing promise for improving treatment options. • TiumBio Co., Ltd. has submitted a Clinical Trial Application to initiate a Phase 1b investigation of TU7710, a new recombinant activated factor VII for hemophilia patients with inhibitors. • The FDA approved ALTUVIIIO (efanesoctocog alfa) in February 2023, a factor VIII replacement therapy for adults and children with Hemophilia A, for routine prophylaxis and on-demand treatment. • BioMarin received FDA approval for Roctavian in June 2023, a single-dose gene therapy for severe Hemophilia A, marking a significant advancement in treatment.

EU Approves Sanofi's Cablivi as First Targeted Therapy for Rare Blood Clotting Disorder aTTP

7 years ago

• The European Commission has authorized Cablivi (caplacizumab) as the first specific treatment for acquired thrombotic thrombocytopenic purpura (aTTP), a rare and life-threatening blood clotting disorder. • Clinical trials involving 220 adults demonstrated Cablivi significantly reduced platelet count normalization time and decreased aTTP-related complications when added to standard care, with no deaths reported in the treatment group. • The approval marks a significant advancement in aTTP treatment, where current standard therapy still carries up to 20% mortality rate, with Cablivi also under priority review by the FDA.