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October 1, 2021September 29, 2021 – The U.S. FDA has approved LivmarliTM (maralixibat) oral solution to treat cholestatic pruritus in patients who are at least one year old and have been diagnosed with Alagille syndrome (ALGS).
- Livmarli is the first drug to receive FDA approval for an ALGS indication.
- ALGS is a rare genetic condition that causes liver disease. Most patients develop cholestatic pruritus (itching associated with liver disease) by the time they are three years old. Pruritus from ALGS is some of the most severe itching associated with any chronic liver disease and can be debilitating.
- Recommended dosing is as follows:
- Starting Dose: 190mcg/kg of patient’s body weight taken by mouth once daily, taken at least 30 minutes before the first meal of the day.
- Maintenance Dose: After one week on the starting dose, increase to 380mcg/kg once daily as tolerated. There is a maximum daily dose of 28.5mg per day for patients who weigh more than 70kg (154 pounds).
- Manufactured by Mirum Pharmaceuticals, Livmarli has a wholesale acquisition cost (WAC) of $46,500 per 30mL bottle (9.5mg/mL)