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The U.S. Food and Drug Administration (FDA) awarded fast-track designation (FTD) to Sanofi's oral Bruton tyrosine kinase (BTK) inhibitor, Rilzabrutinib, which is likely to be the first BTK inhibitor to treat immunoplate plateroid reduction (ITP).
after obtaining a 1/2 positive result, Sanofi has now launched a Phase 3 study to assess the use of rilzabrutinib for the treatment of ITP.
Rilzabrutinib Treatment ITP was awarded the FDA's Orphan Drug Designation in October 2018.
about immunoplate plateroid reduction ITP is due to immuno-mediated plateplate damage and damage to production, which in turn leads to downstream plateplate reduction and prone to bleeding.
there are still unsolved medical needs in patients with relapsed corticosteroid hormones or incurable ITP.
photo source: About Rilzabrutinib Rilzabrutinib is an oral reversible BTK inhibitor that is being studied for the treatment of immuno-mediated diseases.
be involved in congenital and adaptive immune responses through BTK, which is a signaling molecule in immuno-mediated diseases.
Rilzabrutinib's data demonstrate its ability to block inflammatory immune cells, eliminate damaging signals from autoantibodies, and prevent the production of new autoantibodies without depleting B cells.
clinical significance of these mechanisms is currently under study and their safety and importance have not yet been reviewed by regulators.
picture source: