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news.Japanese pharmaceutical firm Kyowa Hakko Kirin has submitted an application to Japan's Ministry of Health, Labour and Welfare (MHLW) for marketing approval of Regpara Tablets 12.5mg (cinacalcet hydrochloride).
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Launched in January 2008 for secondary hyperparathyroidism (HPT) in patients who are undergoing regular dialysis, Regpara tablets 25mg and 75mg acts on calcium receptors on the parathyroid gland to suppress the secretion of parathyroid hormone (PTH).
In February 2014, Regpara had secured approval for hypercalcemia in patients with parathyroid carcinoma, and hypercalcemia in patients with primary HPT who are unable to undergo parathyroidectomy or who experience recurrent primary HPT.
The company said that Regpara has been marketed in Japan for six years and used to treat many patients, but individual patients vary in their response to or tolerance of the drug.
Therefore, the company has applied for manufacturing and marketing approval of Regpara Tablets 12.5mg to provide a lower dosage form to allow doctors to finely adjust the drug dose.
The company is focusing on kidney area, along with three other focused areas as its category-based strategy.