Sanofi FR Stock Price, News & Analysis

Regeneron Pharmaceuticals and Sanofi announced a positive opinion from the European Medicines Agency (EMA) recommending Dupixent (dupilumab) for treating adults with moderate-to-severe prurigo nodularis. If approved, Dupixent will be the first targeted medicine for this condition in the EU. Supported by two pivotal Phase 3 trials, the drug significantly improved itch, skin lesions, and health-related quality of life. Dupixent is already FDA-approved for the same indication in the U.S. The final decision from the European Commission is anticipated shortly.

Regeneron Pharmaceuticals and Sanofi reported positive results from a Phase 3 trial of Dupixent (dupilumab) for treating eosinophilic esophagitis (EoE) in children aged 1 to 11 years. At week 16, up to 68% of children on a higher dose achieved significant disease remission, exceeding the 3% in the placebo group (p<0.0001). The trial suggests Dupixent can improve esophageal damage and promote healthy weight gain in this vulnerable population. Safety data indicated similar adverse event rates compared to placebo, with common issues being mild and manageable. The data has been submitted to global regulatory authorities.

Sanofi US has entered a co-promotion agreement with Provention Bio for the commercialization of teplizumab, an investigational therapy aimed at delaying type 1 diabetes (T1D). Pending FDA approval expected on November 17, 2022, Sanofi will utilize its established diabetes care teams to promote the therapy. Provention Bio retains rights and responsibilities for R&D, while Sanofi will make an upfront payment of $20 million and commit to a potential equity investment of $35 million following FDA approval.

Regeneron Pharmaceuticals and Sanofi announced the FDA's approval of Dupixent (dupilumab) for treating prurigo nodularis in adults, marking it as the first approved therapy for this chronic skin condition. This decision impacts about 75,000 adults in the U.S. affected by prurigo nodularis, a disease characterized by severe itching and skin lesions. The approval followed positive outcomes from pivotal Phase 3 trials, where Dupixent demonstrated significant reductions in itch and skin lesions compared to placebo. Safety data were consistent with known profiles, with common adverse events including nasopharyngitis and conjunctivitis.

Regeneron Pharmaceuticals and Sanofi announced the publication of significant Phase 3 trial results for Dupixent (dupilumab) in treating children aged 6 months to 5 years with uncontrolled atopic dermatitis. The study demonstrated that Dupixent, in combination with low-potency topical corticosteroids, improved skin clearance, reduced severity of disease, and lessened itch compared to placebo. Safety profiles were consistent with older children. The FDA approved Dupixent for this age group in June 2022, with further regulatory reviews ongoing in Europe.

Regeneron Pharmaceuticals and Sanofi announced positive results from the second Phase 3 trial of Dupixent (dupilumab) for treating prurigo nodularis. At 24 weeks, 60% of patients on Dupixent reported significant itch reduction compared to 18% on placebo. Nearly three times as many Dupixent patients achieved clear skin (48% vs. 18% placebo). Submissions for regulatory approvals are underway in the U.S. and EU. Safety results aligned with established profiles, showing a lower rate of severe adverse events.

Regeneron Pharmaceuticals and Sanofi announced positive results from the longest global Phase 3 trial of Dupixent (dupilumab) in children aged 6 to 11 with uncontrolled moderate-to-severe asthma. The trial showed sustained improvement in lung function and a low rate of severe asthma attacks over two years. Dupixent demonstrated an average of 0.118-0.124 severe asthma attacks per year compared to 2.16-2.56 at baseline. These findings were presented at the 2022 ERS International Congress, coinciding with over 500,000 patients treated with Dupixent worldwide.

The CDC has updated its guidance, recommending Sanofi's Fluzone® High-Dose Quadrivalent and Flublok® Quadrivalent influenza vaccines for adults aged 65 and older. This preferential recommendation aims to reduce flu incidence and complications in this high-risk group. Clinical trials show these vaccines are more effective than standard doses, with Fluzone High-Dose reducing hospitalizations due to flu-related issues by 18% and pneumonia by 28%. Sanofi emphasizes its commitment to improving flu vaccination access for older adults.

Sanofi hosted a panel with public health experts on August 12, 2022, to emphasize the importance of flu vaccinations, especially for high-risk groups like those over 65 and minority communities. The discussion addressed disparities in vaccine uptake among Black Americans and the elderly, both of whom face higher hospitalization risks. Experts predict an uptick in flu cases this season, highlighting the need for effective vaccination strategies. Sanofi aims to combat vaccine fatigue and improve access to flu vaccines through partnerships with healthcare organizations.