Sanofi's reversible BTK inhibitor rilzabrutinib has gained the US Food and Drug Administration’s (FDA) orphan drug designation.

Rilzabrutinib is currently under regulatory review in the US, EU and China for potential use in immune thrombocytopenia Paris, April 3, 2025. The US Food and Drug Administration (FDA) has granted ...

Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicinesDesignation granted for warm autoimmune ...

Sanofi SNY announced that the FDA has granted orphan drug designation to its investigational BTK inhibitor, rilzabrutinib, for the treatment of warm autoimmune hemolytic anemia (wAIHA) and IgG4 ...

Results from Phase II studies demonstrated that rilzabrutinib showed clinically meaningful outcomes in patients with warm autoimmune hemolytic anemia and IgG4-related disease.

The FDA has granted orphan drug designation to rilzabrutinib for IgG4-related disease and warm autoimmune hemolytic anemia, according to a press release from the manufacturer. There are currently ...

Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicines Designation granted for warm autoimmune hemolytic anemia and IgG4-related disease ...

Designation granted for warm autoimmune hemolytic anemia and IgG4-related disease Rilzabrutinib is currently under regulatory review in the US, EU and China for potential use in immune ...

Rilzabrutinib is currently under regulatory review in the US, EU and China for potential use in immune thrombocytopenia Paris, April 3, 2025. The US Food and Drug Administration (FDA) has granted ...