Affymax (AFFY), Takeda Get FDA Approval for Anemia Treatment OMONTYS
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Affymax, Inc. (Nasdaq: AFFY) and Takeda Pharmaceutical Company Limited, announced that the U.S. Food and Drug Administration (FDA) approved OMONTYS (peginesatide) Injection for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. OMONTYS is the only once-monthly erythropoiesis-stimulating agent (ESA) for anemia to be made available to the dialysis patient population in the United States.
The FDA’s decision was based on a New Drug Application (NDA), which included results from two randomized, controlled, open-label, Phase 3 studies (EMERALD 1 and 2) that demonstrated the safety and efficacy of OMONTYS dosed once monthly, compared to epoetin dosed between one-to-three times per week (according to product labels), in maintaining hemoglobin (Hb) levels in anemic CKD patients on dialysis. In these studies, the most commonly reported adverse reactions were shortness of breath, diarrhea, nausea, cough and arteriovenous fistula site complication. The EMERALD studies were part of the largest clinical program to support the NDA of an ESA in the treatment of anemia in CKD. Enrolling 2,606 patients, including approximately 1,600 dialysis patients, the OMONTYS Phase 3 program was also the first to prospectively compare, in a head-to-head manner, the cardiovascular safety of different ESAs. Cardiovascular safety was evaluated based on a composite cardiovascular safety endpoint adjudicated by a blinded and independent committee. See below for Important Safety Information about OMONTYS, including Boxed Warnings as well as limitations of use.
In the approval action letter, the FDA outlined post-marketing requirements: an observational study and a randomized controlled trial to be completed with final reports submitted in 2018 and 2019, respectively. The objectives of the studies are to evaluate cardiovascular safety and assess safety of long-term use in adult patients on dialysis, in particular in the incident patient population. In addition, the post-marketing commitment includes the initiation of pediatric studies with target dates for completion between 2016 and 2027. Letters will be sent to nephrology healthcare providers as part of a Risk Evaluation and Mitigation Strategy (REMS) to inform them that OMONTYS is not indicated in patients with CKD not on dialysis. In two trials of OMONTYS, patients with CKD not on dialysis experienced increased specific cardiovascular events.
The FDA’s decision was based on a New Drug Application (NDA), which included results from two randomized, controlled, open-label, Phase 3 studies (EMERALD 1 and 2) that demonstrated the safety and efficacy of OMONTYS dosed once monthly, compared to epoetin dosed between one-to-three times per week (according to product labels), in maintaining hemoglobin (Hb) levels in anemic CKD patients on dialysis. In these studies, the most commonly reported adverse reactions were shortness of breath, diarrhea, nausea, cough and arteriovenous fistula site complication. The EMERALD studies were part of the largest clinical program to support the NDA of an ESA in the treatment of anemia in CKD. Enrolling 2,606 patients, including approximately 1,600 dialysis patients, the OMONTYS Phase 3 program was also the first to prospectively compare, in a head-to-head manner, the cardiovascular safety of different ESAs. Cardiovascular safety was evaluated based on a composite cardiovascular safety endpoint adjudicated by a blinded and independent committee. See below for Important Safety Information about OMONTYS, including Boxed Warnings as well as limitations of use.
In the approval action letter, the FDA outlined post-marketing requirements: an observational study and a randomized controlled trial to be completed with final reports submitted in 2018 and 2019, respectively. The objectives of the studies are to evaluate cardiovascular safety and assess safety of long-term use in adult patients on dialysis, in particular in the incident patient population. In addition, the post-marketing commitment includes the initiation of pediatric studies with target dates for completion between 2016 and 2027. Letters will be sent to nephrology healthcare providers as part of a Risk Evaluation and Mitigation Strategy (REMS) to inform them that OMONTYS is not indicated in patients with CKD not on dialysis. In two trials of OMONTYS, patients with CKD not on dialysis experienced increased specific cardiovascular events.
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