Sanofi US News

-Company resubmits Biologics License Application (BLA) for teplizumab for the delay of clinical type 1 diabetes (T1D) in at-risk individuals to the U.S. Food and Drug Administration (FDA)-

If approved, Dupixent will be the first biologic medicine available in the U.S. to treat uncontrolled moderate-to-severe atopic dermatitis for these young children

Enjaymo is the only approved treatment to decrease the need for red blood cell transfusion due to hemolysis, the destruction of red blood cells, in adults with cold agglutinin disease (CAD)

Late-breaking pivotal data show significant disease improvements in eosinophilic esophagitis and also in chronic spontaneous urticaria

- Company to Host Conference Call Tomorrow, January 28th at 8:00 AM ET -

- PRV-3279 is Designed to Intercept B-Cell Mediated Autoimmune Diseases -

Dupixent is the first and only medicine to demonstrate positive Phase 3 results in prurigo nodularis, confirming the potential benefit of targeting IL-4 and IL-13, central drivers of type 2 inflammation, to address itch and skin lesions

Dupixent significantly improved skin clearance and reduced overall disease severity and itch in a Pivotal trial that met all primary and secondary endpoints

Sarclisa combination therapy is first to demonstrate superiority to standard of care lenalidomide, bortezomib and dexamethasone (RVd) in a Phase 3 trial

Dupixent significantly reduced severe asthma attacks and improved lung function and asthma control in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma

* Regardless of gender or sexual orientation, employees welcoming a child into their family receive equal amount of paid time off

Andrew Drechsler to Retire as Chief Financial Officer in December

PRV-101 was well tolerated and elicited high titers of virus-neutralizing antibodies in a dose-dependent fashion in healthy volunteers

Dupixent 300 mg weekly significantly improved the ability to swallow and reduced eosinophils in the esophagus compared to placebo, reinforcing positive results from first Phase 3 trial

Pivotal trial met primary and all key secondary endpoints

Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial, supporting potential as a best-in-class option

First study to investigate the safety and immunogenicity of both vaccines when co-administered compared to each vaccine administered separately in adults aged 65 years and older

Presentations focused on respiratory syncytial virus, meningococcal disease, and influenza

*Phase 3 trial met its primary and key secondary endpoints

Data collection completed for PROTECT Pharmacokinetic/Pharmacodynamic (PK/PD) substudy

Dupixent rapidly improved symptoms after first dose, improving itch in one week and skin clearance in two weeks

Approval is based on positive Phase 3 data demonstrating improvements in key disease burden measures and establishing its safety profile

Libtayo combined with chemotherapy increased median overall survival from 13 to 22 months, leading to a 29% reduction in the risk of death

Fifth disease that Dupixent has demonstrated positive pivotal results

Designation is the first step in a new MHRA initiative to accelerate the development and access to innovative medicines in the UK post-Brexit

Previously reported pharmacokinetic (PK) drug product comparability considerations remain outstanding

New research from first-in-class marketed and investigational therapies in hemophilia, immune thrombocytopenia and acquired thrombotic thrombocytopenic purpura will be presented

* Study also shows more people on Soliqua 100/33 had improved blood sugar control without weight gain and without low blood sugar events (hypoglycemia) in first head-to-head comparison with premixed insulin