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news.Kyowa Hakko Kirin has announced that it has been obtained an approval for additional dosage and administration for hypercalcemia in patients with parathyroid carcinoma, and hypercalcemia in patients with primary hyperparathyroidism (HPT) who are unable to undergo parathyroidectomy (PTx) or who experience recurrent primary HPT of Regpara tablets 25mg and 75mg (generic name: cinacalcet hydrochloride) from Japan's Ministry of Health, Labour and Welfare.
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Regpara acts on calcium receptors on the parathyroid gland to suppress the secretion of parathyroid hormone (PTH). The drug was approved in Japan for secondary HPT in patients who are undergoing regular dialysis in 2007 and was launched in January 2008.
Overseas (except for Asia), Amgen Inc. developed the drug (Brand name; Sensipar/Mimpara) and has obtained approval for the indications of secondary HPT in patients with chronic kidney disease on dialysis in 59 countries (as of February 2013), and hypercalcemia in patients with parathyroid carcinoma and primary HPT who are unable to undergo PTx in all but a few of the countries where the Drug is approved and available.
Under these circumstances, the Japan Endocrine Society, Japanese Society of Thyroid Surgery, and Japan Associate of Endocrine Surgeons submitted a letter to the MHLW requesting the development of Regpara to treat hypercalcemia in patients with parathyroid carcinoma in August 2009.
As a result of deliberations by the ‘Review Committee on Unapproved Drugs and Indication with High Medical Needs’, Regpara was determined as being of high medical need and in December 2010 the MHLW requested Kyowa Hakko Kirin to develop the additional indication for hypercalcemia in patients with parathyroid carcinoma.
In response to this request, Kyowa Hakko Kirin entered Phase III clinical trial for the additional indication in Japan. Based on the results of clinical trial in Japan and overseas clinical studies by Amgen, Kyowa Hakko Kirin filed for approval of this additional indication in June 2013, and has received the approval today. Regpara was also granted an orphan drug designation for this indication by the MHLW.
Kyowa Hakko Kirin expects that the approval for additional indication for administration and dosage will significantly contribute to the treatment of hypercalcemia in patients with parathyroid carcinoma, and hypercalcemia in patients with primary HPT who are unable to undergo PTx or who experience recurrent primary HPT.