Rigel Announces Availability of REZLIDHIA™ (olutasidenib) in the U.S. for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with a Susceptible IDH1 Mutation

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[{"type":"text","content":"SOUTH SAN FRANCISCO, Calif., Dec. 22, 2022 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), today announced that REZLIDHIA™ (olutasidenib) capsules are available in the U.S. by prescription 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. REZLIDHIA is an oral, small molecule, inhibitor of mutated IDH1 designed to bind to and inhibit mIDH1 to reduce 2-hydroxyglutarate levels and restore normal cellular differentiation of myeloid cells. REZLIDHIA was approved by the U.S. Food and Drug Administration (FDA) on December 1, 2022.\n\"We are pleased to launch REZLIDHIA today in the U.S. and are ready to provide access to patients,\" said Raul Rodriguez, Rigel's president and CEO. \"REZLIDHIA is Rigel's second commercial product and is a new and promising oral treatment option for mIDH1 R/R AML patients who typically experience poor clinical outcomes. With durable efficacy data, promising overall survival, and a well characterized safety profile, we are excited to bring REZLIDHIA to patients in need.\"\nThe recommended dosage of REZLIDHIA is 150 mg taken orally twice daily. Based on the recommended dosage, the wholesale acquisition cost (WAC) of REZLIDHIA in the U.S. is $32,200 per month. REZLIDHIA is supplied as follows:\nNDC Number\nProduct\nPackage\nWAC\n71332-005-01\nOral capsule 150 mg\nBottle - 30 capsules each\n$16,100\nTo assist with access to REZLIDHIA, RIGEL ONECARE®, a comprehensive patient support center, can help patients and physicians as they navigate through insurance coverage requirements and provide financial assistance when needed and if eligible, along with other support programs. Patients will be assigned a Nurse Navigator to assess the patient's individual case.\nTo learn more, visit www.REZLIDHIA.com or contact RIGEL ONECARE at 833-RIGELOC (833-744-3562).\nIn August 2022, Rigel and Forma Therapeutics, Inc. announced they entered an exclusive, worldwide license agreement to develop, manufacture and commercialize REZLIDHIA. Under the terms of the agreement, Rigel is responsible for the launch and commercialization of REZLIDHIA in the U.S., and intends to work with potential partners to further develop and commercialize the product outside the U.S.\nAbout AMLAc...

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