Sanofi’s Wayrilz approved in USA for immune thrombocytopenia

The US Food and Drug Administration (FDA) has approved French pharma major Sanofi’s (Euronext: SAN) Wayrilz (rilzabrutinib) for adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

The approval was based on the pivotal LUNA 3 Phase III study, in which Wayrilz met the primary and secondary endpoints, showing a positive impact on sustained platelet counts and other ITP symptoms. It is the first Bruton’s tyrosine kinase (BTK) inhibitor authorized for ITP.