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USA 113 , E71E80 (2016)

With regard to the substantial clinical improvement criterion, the applicant asserted that TERLIVAZ represents a substantial clinical improvement over existing technologies because among HRS patients who failed previous therapy with available off-label treatments, TERLIVAZ has been shown to significantly improve renal function

Age : Typically considered for young to middle-aged patients (under 50 years old) who are otherwise in good health, as this group tends to have better long-term outcomes with OCA

Also of concern is the possibility of Steven Johnson syndrome, in which the top layer of the skin dies and is shed a medical emergency