KHK Seeks Japanese Approval For New Regpara Dosage


Kyowa Hakko Kirin (KHK) has filed an application for marketing approval to Japan's Ministry of Health, Labour and Welfare for Regpara tablets 12.5mg (cinacalcet hydrochloride). Regpara is already marketed in 25 and 75mg dosages; the new dosage will complement these. KHK applied for manufacturing and marketing approval of the 12.5mg dosage to provide a lower dosage form to allow doctors to finely adjust the drug dose.

Regpara acts on calcium receptors on the parathyroid gland to suppress the secretion of parathyroid hormone. The 25 and 75mg dosages were launched in January 2008 for secondary hyperparathyroidism (HPT) in patients who are undergoing regular dialysis. In February 2014, the drug had received approval for hypercalcaemia in patients with parathyroid carcinoma, and hypercalcaemia in patients with primary HPT who are unable to undergo parathyroidectomy or who experience recurrent primary HPT.

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Related sectors of this article: Pharmaceuticals & Healthcare, Regulatory - Pharmaceuticals & Healthcare, Therapy Areas
Geography: Japan