Press Releases

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

News Summary: * Isatuximab, an investigational anti-CD38 monoclonal antibody, added to pomalidomide and dexamethasone prolonged progression free survival by 5 months compared to pomalidomide and dexamethasone alone (11.53 vs. 6.47 months, p=0.001, HR 0.596) * Overall response rate significantly greater with isatuximab combination therapy compared to pomalidomide and dexamethasone (60% vs. 35%, p<0.0001) * First positive randomized Phase 3 trial to evaluate an antibody in combination with pomalidomide and dexamethasone presented at this year’s ASCO annual meeting * European Medicines Agency accepted for review the Marketing Authorization Application for isatuximab

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

* New data at ASCO include more than double the patients previously reported; median overall survival still not reached with a median follow-up of up to 17 months

* 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)