Sanofi US News

U.S. FDA submission for children planned for 4Q 2019

* First biologic medicine for adults with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP)

- Pivotal Phase 3 data evaluated isatuximab (anti-CD38) in combination with pomalidomide/dexamethasone in prolonging progression-free survival in relapsed/refractory multiple myeloma

* Only biologic approved in the EU for severe asthma with type 2 inflammation, as characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO)

* Praluent is the first PCSK9 inhibitor that has shown a meaningful reduction in death from any cause

* Sanofi continues its commitment to helping reduce cost burden for people living with diabetes with first-ever insulin savings program

* Only therapy that targets the IL-4/IL-13 pathway, a key driver of the allergic or type 2 inflammation that underlies atopic dermatitis

* Soliqua 100/33 now approved as an add-on to diet and exercise for adults with type 2 diabetes

* This is the latest step by the companies to help make Praluent more accessible and affordable for appropriate patients

- First medicine approved in the U.S. specifically for the treatment of aTTP, a rare blood-clotting disorder

- The 0.5 mL dose is now approved for use in children 6 months through 35 months of age

* First and only vaccine approved in the U.S. for repeat vaccination 8 years or more after the first vaccination to help protect against tetanus, diphtheria and pertussis, offering flexibility for health care providers to help manage their immunization schedules(2)

-HERCULES Phase 3 trial met its primary endpoint, demonstrating that treatment with Cablivi resulted in a significantly faster time to platelet count response in patients with acquired thrombotic thrombocytopenic purpura (aTTP) when administered in conjunction with plasma exchange and immunosuppression

* Mortality risk reduction greater in patients treated for at least 3 years or those with baseline LDL-C levels of at least 100 mg/dL