The company Sanofi (XPAR-SAN) has received regulatory clearance from the U.S. Food and Drug Administration for Wayrilz, a new therapeutic option targeting chronic immune thrombocytopenia (ITP) in adults who have not responded adequately to prior treatments.
The approval follows positive results from the Luna 3 Phase 3 clinical trial, where Wayrilz achieved both primary and secondary endpoints. The study demonstrated sustained improvements in platelet counts and symptom management, reinforcing the drug’s potential in addressing this autoimmune condition.
Chronic immune thrombocytopenia is characterized by the immune system mistakenly attacking platelets, resulting in abnormally low levels and increased bleeding risk. Wayrilz, a BTK inhibitor, represents a novel approach in the treatment landscape.
The drug was previously approved in the United Arab Emirates in June and is currently undergoing regulatory review in the European Union and China, signaling Sanofi’s broader global ambitions for the product. Investors may view the FDA approval as a strategic milestone in Sanofi’s immunology portfolio, potentially contributing to future revenue growth and market expansion.