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生物制药、医疗公司OPKO Health在6月21日宣布,美国FDA批准了该公司的25-羟基维生素D3(骨化二醇)缓释胶囊Rayaldee上市,用于治疗成人3或4期慢性肾病(CKD)患者因维生素D不足引起的的继发性甲状旁腺功能亢进(secondary hyperparathyroidism,SHPT)。这类患者因肾脏功能障碍造成血浆的25-羟基维生素D3水平低于30纳克/毫升,而通过Rayaldee治疗血浆的25-羟基维生素D3浓度有望恢复至30纳克/毫升或更高,并降低升高的血浆甲状旁腺激素(PTH)水平。
OPKO Health, a biopharmaceutical and medical company, announced on June 21 that the U.S. FDA approved the company’s listing of Rayaldee, a 25-hydroxyvitamin D3 sustained release capsule for the treatment of CKD in adults with stage 3 or 4 disease ) Patients with secondary hyperparathyroidism (SHPT) due to vitamin D deficiency. Plasma levels of 25-hydroxyvitamin D3 in these patients are below 30 ng / mL due to renal dysfunction while the 25-hydroxyvitamin D3 concentration in plasma treated with Rayaldee is expected to return to 30 ng / mL or more and decrease Elevated plasma parathyroid hormone (PTH) levels.