Tuesday, April 16, 2024

First Approved Therapy for Cholestatic Pruritus in Taiwan: LIVMARLI

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LIVMARLI is recognized as the foremost and sole approved therapy in Taiwan for the treatment of cholestatic pruritus in ALGS patients who are at least one year old. This ileal bile acid transporter (IBAT) inhibitor has received approval in Canada, mainland China, and Hong Kong. Its acceptance extends to Europe for treating ALGS patients aged two months and over, and in the US for those aged three months and over.

CANbridge Pharmaceuticals was granted exclusive licensing rights from Mirum Pharmaceuticals for the development, commercialization, and manufacturing of LIVMARLI in Greater China. The approval for the therapy covers three rare liver diseases, namely progressive familial intrahepatic cholestasis, biliary atresia (BA), and Alagille syndrome, as well as a selection of other indications.

The endorsement of LIVMARLI is informed by data from Mirum’s pivotal ICONIC study and the RISE infant safety study, in addition to data gathered from the programs in ALGS patients. The ICONIC study revealed statistically significant and clinically meaningful reductions in pruritus and serum bile acids when compared to a placebo.

Supporting evidence for the use of LIVMARLI in the infant group aged less than 12 months was also gleaned from interim data from the RISE study. Currently, the therapy is being evaluated in a global Phase II EMBARK study for the treatment of BA, which concluded patient enrollment in China in May this year.

James Xue, the founder, chairman, and CEO of CANbridge Pharmaceuticals, has expressed his delight at the approval of LIVMARLI in Taiwan. He emphasizes that this approval, along with those in mainland China and Hong Kong in the preceding six months, signifies a significant step forward in their mission to improve the lives of rare disease patients.

The availability of LIVMARLI in Taiwan is seen as a significant turning point in addressing the distinct challenges that individuals affected by ALGS face.

The approval of LIVMARLI for the treatment of cholestatic pruritus in ALGS patients marks a major milestone in Taiwan’s healthcare sector. The therapy’s proven effectiveness, demonstrated in the ICONIC and RISE studies, provides hope for patients suffering from this rare liver disease. Its availability signifies a significant step forward in addressing the challenges faced by ALGS patients, offering them a new, effective treatment option.

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