Mirum Pharmaceuticals (MIRM) said Monday that the US Food and Drug Administration has approved its Ctexli tablets, a bile acid treatment for adults with cerebrotendinous xanthomatosis, a rare genetic disorder that impairs cholesterol breakdown.
The company said the approval is based on late-stage trial data showing Ctexli significantly reduced bile alcohols, addressing a deficiency of chenodeoxycholic acid in patients.
Ctexli will be available through Mirum's patient support program, Mirum Access Plus, the company said.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.