Ipsen's Odevixibat Granted Approval in China as a Clinically Urgent Drug for PFIC

On December 3, the NMPA official website showedIpsen's "Odevixibat" Approved in China,Used forTreatment of Progressive Familial Intrahepatic Cholestasis (PFIC) in Patients for 6 Months or Longer。

Screenshot source: NMPA official website

Odevixibat is a highly selective, non-systemic ileal bile acid transporter inhibitor that alleviates cholestasis and improves pruritus and sleep.

Currently, there are no specific drugs for PFIC. Reducing serum bile acid concentration in these patients, alleviating their pruritus symptoms, preventing the progression of liver disease, and improving quality of life are the current therapeutic strategies of concern.

The commonly used drugs for cholestasis currently include the following two categories:First, it promotes bile acid excretion.Ursodeoxycholic Acid, This class of drugs can promote bile acid secretion through competitive mechanisms, offering some therapeutic value for early- and mid-stage patients, but their effect is limited; secondly, bile acid sequestrantsCholestyramine, which reduces the reabsorption of bile acids in the enterohepatic circulation by binding to bile acids in the intestine. However, clinical complications such as bloating, diarrhea, and abdominal pain are common, and patients have poor tolerance.Therefore, in the research field of PFIC, the development of therapeutic drugs is crucial.

Odevixibat is an inhibitor of the ileal mucosal cell bile acid transporter protein,It can block the reabsorption of intestinal bile acids into the liver through the enterohepatic circulation, thereby reducing the concentration of bile acids within the liver and in circulation.Given its pharmacological effects, several studies have been conducted to explore its efficacy in treating cholestatic diseases, particularly PFIC. In 2021, the U.S. FDA and the European EMA approved it as a drug for treating PFIC.

Odevixibat, as a clinically urgently needed drug, has been approved this time.Clinical Exemption PathwayApproved in China, providing a new treatment option for Chinese PFIC patients.

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