Tags : Aged

Regulatory

Regeneron and Sanofi Report the US FDA’s Acceptance of sBLA

Shots: The sBLA is based on P-III study assessing Dupixent + SOC maintenance therapy in children aged 6-11yrs. with moderate-to-severe asthma with type 2 inflammation The study resulted in a reduction of severe asthma attacks and rapidly improved lung function within 2wks, safety results were generally consistent with the known safety profile of Dupixent. Dupixent […]Read More

Regulatory

Amgen’s Nplate (Romiplostim) Receives FDA’s Approval for Immune Thrombocytopenia Aged

Shots: The approval is based on P-III & P-I/II study results assessing Nplate vs PBO in pediatric patients with Immune Thrombocytopenia (ITP) for at least six months who had no response to corticosteroids, immunoglobulins or splenectomy The  P-III & P-I/II study demonstrated increase in overall platelet response (71% vs 20%) with durable platelet response (52% vs 10%) Nplate is a thrombopoietin […]Read More