Mirum Pharmaceuticals
NEWS
Wednesday’s FDA approval expands Mirum’s Livmarli into the rare genetic disorder that causes progressive liver disease. The biotech has also filed a supplemental New Drug Application for a higher dose of the drug and allowing its use in younger patients.
The FDA’s busy week ahead involves three decision dates for potential industry firsts and a highly anticipated advisory committee meeting for two CAR-T therapies.
Mirum Pharmaceuticals announced that Livmarli oral solution met its primary endpoint in the Phase III MARCH study in young patients with progressive familial intrahepatic cholestasis.
With the last full week before the Thanksgiving week in the U.S., companies had a fair amount of clinical trial news. Here’s a look.
LIVMARLI is indicated for ages one year and older and will now be accessible to patients with a prescription through Mirum Access Plus. Here’s more about it.
The U.S. Food and Drug Administration is wrapping up the end of September and beginning October with two PDUFA dates. Here’s a look.
As is typical, the second day of the JP Morgan Annual Healthcare Conference—conducted virtually this year because of the pandemic—had plenty of news from the largest biopharma companies globally.
The rolling NDA was somewhat expected after an end-of-phase meeting with the FDA earlier this year turned into a pre-NDA meeting with the regulatory agency.
Mirum Pharmaceuticals entered 2020 with a significant bounce after the U.S. Food and Drug Administration turned an end-of-phase meeting into a pre-New Drug Application meeting for its lead asset, maralixibat, an investigational treatment being evaluated for pediatric patients with Alagille syndrome.
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