Sanofi Gets FDA Nod for Wayrilz in Immune Thrombocytopenia

Core Insights - Sanofi has received FDA approval for Wayrilz (rilzabrutinib), marking it as the first BTK inhibitor approved for treating persistent or chronic immune thrombocytopenia (ITP) in the United States [1][7] - The approval was based on the phase III LUNA 3 study, which demonstrated positive outcomes in sustained platelet counts and ITP symptoms, achieving both primary and secondary endpoints [2][7] - Wayrilz is also under review in the EU and China for ITP treatment and has been recently approved in the UAE for the same indication [3] Company Developments - Patients using Wayrilz will benefit from Sanofi's HemAssist program, which offers support for treatments related to rare blood disorders [3] - In addition to ITP, Wayrilz is being developed for other rare diseases, including IgG4-related disease (IgG4-RD) and warm autoimmune hemolytic anemia (wAIHA), with orphan drug designations from the FDA [5][9] - A phase II study is currently evaluating Wayrilz for IgG4-RD, a chronic immune-mediated condition affecting multiple organs [8] Stock Performance - Sanofi's shares have increased by 2.6% this year, contrasting with a 0.6% decline in the industry [4]