JCR receives an approval from MHLW (Japan) for expanded indication of Growject in short stature due to SHOX-deficiency.
JCR Pharmaceuticals Co., Ltd. announced that JCR has received an approval from the Ministry of Health, Labour and Welfare of Japan for an expanded indication of Growject S.C. Injection 6mg and Growject S.C. Injection 12mg (INN?somatropin), a recombinant human growth hormone product, for the treatment of short stature caused by alterations of the Short Stature Homeobox-containing Gene (SHOX).
SHOX deficiency is a congenital disorder caused by micro deletions, duplications, or mutations that result in loss of function of a growth-gene SHOX presents on the sex chromosomes. The disease presents with growth failure due to an underlying genetic alteration. Growject is the first approved growth hormone for the treatment of short stature due to SHOX deficiency in Japan. Growject is approved in Japan and prescribed for the treatment of short stature due to pediatric growth hormone deficiency, Turner syndrome, small for gestational age, and for adult growth hormone deficiency. Short stature due to SHOX deficiency becomes the fifth indication approved.
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