CHICAGO , Aug. 19, 2024 /PRNewswire/ -- RNA Therapeutics, a clinical-stage biotechnology company focused on innovative applications of mRNA-based delivery systems for therapeutic proteins and vaccines, announced that it has received a written response to its Pre-Investigational New Drug Application (pre-IND) questions submitted to the U.S.
Food and Drug Administration (FDA) regarding the development of its lead asset, RNAT-89 (BLA-761423), an mRNA LNP formulation to express darbepoetin, as the first such product presented to the FDA to seek advice on the naming of the product, nonclinical and clinical testing and comparison with Aranesp (Amgen) indicated for the treatment of anemia due to chronic kidney disease (CKD) and non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy. There is no biosimilar to Aranesp in the US. The global market for erythropoietin (EPO) drugs, including darbepoetin, was valued at $9,734.
1 million in 2022 and is projected to reach $16,926.21 million by 2032, with a compound annual growth rate (CAGR) of 5.7%.
The current treatment cost with darbepoetin is about $1,000 , which will be reduced to less than $50 , making it affordable globally. The pre-IND meeting with the FDA clarified several issues, the first being how the product would be named. There was no history of naming such a product, and the FDA agreed with RNA Therapeutics' suggestion to call it "Darbepoetin mRNA (xxxx) Injection.
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