Biotech Values

[DewDiligence]

(OCRX)—Section of Xifaxan FDA label re HE indication:

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022554lbl.pdf

1 INDICATIONS AND USAGE

1.2 Hepatic Encephalopathy

XIFAXAN 550 mg is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients = 18 years of age.

In the trials of XIFAXAN for HE, 91% of the patients were using lactulose concomitantly. Differences in the treatment effect of those patients not using lactulose concomitantly could not be assessed.

XIFAXAN has not been studied in patients with MELD (Model for End-Stage Liver Disease) scores > 25, and only 8.6% of patients in the controlled trial had MELD scores over 19.

Not indicated as a treatment for acute HE.