MIRM - Mirum's liver disease drug Livmarli gets EMA committee nod for approval in EU
- A committee of the European Medicines Agency (EMA) recommended granting marketing authorization under exceptional circumstances to Mirum Pharmaceuticals' ( NASDAQ: MIRM ) Livmarli to treat cholestatic pruritus (itching) in patients two months of age and older with Alagille syndrome (ALGS).
- ALGS is a rare genetic disorder whichcan affect multiple organs, but mainly liver. In the condition, bile builds up in the liver because there are few bile ducts to drain the bile.
- Livmarli will be available as an oral solution, the The EMA's Committee for Medicinal Products for Human Use (CHMP) said on Friday.
- The European Commission, which generally follows the opinion of the CHMP, will now decide on the drug's approval.
- Livmarli was approved in the U.S. in September 2021.
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Mirum's liver disease drug Livmarli gets EMA committee nod for approval in EU