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FDA committee recommends XIFAXAN® approval for hepatic encephalopathy

The Gastrointestinal Drugs Advisory Committee of the FDA has recommended the approval of XIFAXAN® (rifaximin) tablets (550 mg) for the maintenance of remission of hepatic encephalopathy.

‘We are very pleased with the advisory committee’s support for the approval of XIFAXAN 550 mg tablets. If approved, XIFAXAN 550 mg will be the first new option for the management of hepatic encephalopathy in over 30 years,’ stated Bill Forbes, Senior Vice President Research and Development and Chief Development Officer, Salix Pharmaceuticals.

The committee reviewed data from Salix’s 299-subject, double-blind, placebo-controlled and multinational Phase III study. The study demonstrated a statistically significant and clinically meaningful reduction in the risk of recurrent overt hepatic encephalopathy.

The primary endpoint, the risk of experiencing a breakthrough overt hepatic encephalopathy episode, was reduced by 58 percent in XIFAXAN 550 mg-treated subjects compared with placebo (p<0.0001). The key secondary endpoint, risk of experiencing hepatic-encephalopathy-related hospitalization, was reduced by 50 percent in XIFAXAN 550 mg-treated subjects compared with placebo (p = 0.0129).

The committee also reviewed supporting evidence from Salix’s long-term, open-label, Phase III study and evidence derived from clinical studies in acute hepatic encephalopathy, three-month and six-month studies from the published literature and meta-analyses.

Hepatic encephalopathy occurs frequently in patients with cirrhosis as a result of their end-stage liver disease. Typically, the cirrhosis is caused by several factors, such as alcohol and/or drug abuse, chronic viral hepatitis and autoimmune disease. There are more than 600,000 cases of cirrhosis in the USA, and there are reported to be approximately 200,000 patients in the USA with overt hepatic encephalopathy.

Hepatic encephalopathy is a neurological disorder caused by chronic liver failure resulting in cognitive, psychiatric and motor impairments. The condition encompasses a wide spectrum of often reversible neuropsychiatric abnormalities caused by the inability of the liver to remove toxic products in the gut, most notably ammonia produced by bacteria in the GI tract.

The FDA convenes the Gastrointestinal Drugs Advisory Committee to obtain independent expert advice on a broad scope of issues relating to gastrointestinal drug products. The committee provides non-binding recommendations, which will be considered by the FDA in its final review; however, the final decision on approval of the drug is made by the FDA.

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