Rigel Pharmaceuticals Receives Approval from Food and Drug Administration for Tavalisse as Proprietary Name for Fostamatinib in the United States
April 27, 2017 at 07:30 am EDT
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Rigel Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proprietary name Tavalisse™ for the company's investigational product candidate, fostamatinib disodium, an oral spleen tyrosine kinase (SYK) inhibitor. In addition, Rigel has applied to the U.S. Patent and Trademark Office to obtain federal registration of the Tavalisse mark. The name Tavalisse (pronounced - ta vah lees') was developed based on the FDA's Guidance for Industry, Contents of a Complete Submission for the Evaluation of Proprietary Names. Created with the help of experts in this field, the proprietary name development included input from prescribers, pharmacists, linguists and employees to create a unique and approachable name. Earlier this month, the company announced that it submitted a New Drug Application (NDA) to the FDA for Tavalisse in patients with chronic and persistent immune thrombocytopenia (ITP). The FDA previously granted Orphan Drug designation to Tavalisse for the treatment of patients with ITP. The NDA is supported by data from the Phase 3 clinical program for Tavalisse in ITP, which was comprised of three studies, two randomized placebo-controlled studies (Studies 047 and 048) and an open-label extension study (Study 049). In total, 163 ITP patients have been treated with Tavalisse and included in the NDA submission. Across all indications, Tavalisse has been evaluated in over 4,600 subjects.
Rigel Pharmaceuticals, Inc. is a biotechnology company. The Company is engaged in developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. It is focused on products that address signaling pathways that are critical to disease mechanisms. Its first product is TAVALISSE (fostamatinib disodium hexahydrate) tablets, the approved oral spleen tyrosine kinase inhibitor for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Its second product is REZLIDHIA (olutasidenib) capsules for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. Its GAVRETO (pralsetinib) product is a once daily, small molecule, oral, kinase inhibitor of wild type rearranged during transfection (RET) and oncogenic RET fusions.