US2023285376A1PendingUtilityA1

Lomitapide for use in methods of treating hyperlipidemia and hypercholesterolemia in pediatric patients

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Assignee: AMRYT PHARMACEUTICALS INCPriority: Jul 29, 2020Filed: Jul 29, 2021Published: Sep 14, 2023
Est. expiryJul 29, 2040(~14 yrs left)· nominal 20-yr term from priority
A61P 3/06A61K 31/4468
48
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Claims

Abstract

Provided herein are methods of treating hyperlipidemia or hypercholesterolemia in pediatric patients with lomitapide or a pharmaceutically acceptable salt thereof.

Claims

exact text as granted — not AI-modified
What is claimed: 
     
         1 . A method of safely administering lomitapide, or a pharmaceutically acceptable salt thereof, to a pediatric patient comprising:
 (a) administering a first daily dose of about 0.5 mg to about 2.5 mg of lomitapide, or a pharmaceutically acceptable salt thereof to a patient aged 5 to 15 years; and   (b) administering a first daily dose of about 2.5 mg to about 7.5 mg of lomitapide, or a pharmaceutically acceptable salt thereof to a patient aged 16 to 17 years,   wherein the first daily dose is administered to the patient for about 1 to 4 weeks.   
     
     
         2 . A method of treating hyperlipidemia or hypercholesterolemia in a pediatric patient, comprising:
 (a) administering an first daily dose of about 0.5 mg to about 2.5 mg of lomitapide, or a pharmaceutically acceptable salt thereof to a patient's age is 5 to 15 years;   (b) administering a first daily dose of about 2.5 mg to about 7.5 mg of lomitapide, or a pharmaceutically acceptable salt thereof to a patient's age is 16 to 17 years,   wherein the first daily dose is administered to the patient for about 1 to 4 weeks.   
     
     
         3 . A method of treating hyperlipidemia or hypercholesterolemia, comprising:
 administering a first daily dose of about 0.5 mg to about 2.5 mg of lomitapide, or a pharmaceutically acceptable salt thereof to a pediatric patient age 5 to 10 years, wherein the first daily dose is administered to the patient for about 1 to 4 weeks.   
     
     
         4 . A method of treating hyperlipidemia or hypercholesterolemia, comprising:
 administering a first daily dose of about 0.5 mg to about 2.5 mg of lomitapide, or a pharmaceutically acceptable salt thereof to a pediatric patient age 11 to 15 years, wherein the first daily dose is adminstered to the patient for about 1 to 4 weeks.   
     
     
         5 . A method of treating hyperlipidemia or hypercholesterolemia, comprising:
 administering a first daily dose of about 2.5 mg to about 7.5 mg of lomitapide, or a pharmaceutically acceptable salt thereof to a pediatric patient age 16 to 17 years, wherein the first daily dose is administered to the patient for about 1 to 4 weeks.   
     
     
         6 . The method of any one of  claims 1 - 5 , wherein the first daily dose is administered to the patient for about 4 weeks. 
     
     
         7 . The method of any one of  claims 1 - 6 , wherein the patient has homozygous familial hypercholesterolemia.

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