FDA grants fast track designation to rilzabrutinib for immune thrombocytopenia
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The FDA granted fast track designation to rilzabrutinib for treatment of immune thrombocytopenia, according to the agent’s manufacturer.
Rilzabrutinib (Sanofi) is an oral, reversible covalent Bruton tyrosine kinase inhibitor in development for treatment of immune-mediated diseases.
Immune thrombocytopenia (ITP) is a bleeding disorder in which blood does not clot as it should due to a lower number of platelets or thrombocytes.
A phase 1/phase 2 study of rilzabrutinib for ITP yielded positive results, and a phase 3 study has been initiated, according to a Sanofi-issued press release.
“By awarding fast track designation to rilzabrutinib ... the FDA has recognized rilzabrutinib's potential to meaningfully improve outcomes for patients with this debilitating disease,” Dolca Thomas, chief medical officer of Principia, a Sanofi company, said in the release. “This is an excellent acknowledgement as we initiate our phase 3 study.
The FDA previously granted orphan drug designation to rilzabrutinib for ITP.
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