The Taiwan Food and Drug Administration (TFDA) has granted marketing approval to CANbridge Pharmaceuticals’ CAN108 (Maralixibat Chloride Oral Solution/LIVMARLI) for the treatment of cholestatic pruritus in patients with alagille syndrome (ALGS), a rare genetic disorder.
LIVMARLI is claimed to be the first and only approved therapy in Taiwan used for treating cholestatic pruritus in patients with ALGS aged one year or older.
Recently, the minimally absorbed ileal bile acid transporter (IBAT) inhibitor LIVMARLI was recently approved in Canada, mainland China, and Hong Kong.
It has also been approved in Europe to treat patients aged two months and older with ALGS, and in the US for treating patients with ALGS aged three months and older.
CANbridge gained exclusive license rights from Mirum Pharmaceuticals for the development, commercialisation, and manufacturing of LIVMARLI in Greater China for treating three rare liver diseases – progressive familial intrahepatic cholestasis, biliary atresia (BA), and Alagille syndrome, along with other selected indications.
The approval of LIVMARLI is based on data from Mirum’s pivotal ICONIC study and RISE infant safety study, along with the data collected from the programmes in patients with ALGS.
Statistically significant and clinically meaningful reductions in pruritus and serum bile acids, compared to placebo, were observed in the ICONIC study.
Interim data from the RISE study also supported the indication in infant group at age of less than 12 months.
LIVMARLI is currently being assessed in a global Phase II EMBARK study for the treatment of BA, which completed patient enrolment in China in May this year.
CANbridge Pharmaceuticals founder, chairman and CEO James Xue said: “We are thrilled by the approval of LIVMARLI in Taiwan, following the approvals in mainland China and Hong Kong over the span of six months, signifying a major stride forward in our mission to enhance the lives of rare disease patients.
“The availability of LIVMARLI in Taiwan represents a significant turning point in addressing the unique challenges faced by individuals affected by ALGS.”