Hunter syndrome therapeutic agent and treatment method

Abstract

A Hunter syndrome therapeutic agent contains a first composition to be intravenously injected and a second composition to be subcutaneously injected. The agent can reduce the number of visits to the hospital by patients with Hunter syndrome to twice a month or less. It maintains a medicinal effect equivalent to or greater than that of a conventional once-a-week IV injection, increases drug-taking compliance of patients in comparison to conventional therapeutic agents and treatment methods, and enables enhanced patient welfare and convenience.

1 . A formulation for treating Hunter syndrome, comprising a first composition for an intravenous injection and a second composition for a subcutaneous injection. 
     
     
         2 . The formulation for treating Hunter syndrome according to  claim 1 , wherein the first composition is intravenously injected once every two months to twice a month, and the second composition is subcutaneously injected once to seven times a week. 
     
     
         3 . The formulation for treating Hunter syndrome according to  claim 1 , wherein the first composition is intravenously injected once a month, and the second composition is subcutaneously injected once a week. 
     
     
         4 . The formulation for treating Hunter syndrome according to  claim 1 , wherein the first composition is injected at the first week of the month, and the second composition is injected 1 to 7 times per week from the next week to the last week. 
     
     
         5 . The formulation for treating Hunter syndrome according to  claim 1 , wherein the first composition is injected at the first week of the two months, and the second composition is injected 1 to 7 times per week from the next week to the last week of the two months. 
     
     
         6 . The formulation for treating Hunter syndrome according to  claim 1 , wherein the first composition comprises iduronate-2-sulfatase consisting of at least one of the amino acid sequences of SEQ ID NOS: 1 and 2. 
     
     
         7 . The formulation for treating Hunter syndrome according to  claim 1 , wherein the second composition comprises iduronate-2-sulfatase consisting of at least one of the amino acid sequences of SEQ ID NOS: 1 and 2. 
     
     
         8 . The formulation for treating Hunter syndrome according to  claim 1 , wherein the first composition is injected at an effective dose of 0.05 mg/kg to 20 mg/kg per week. 
     
     
         9 . The formulation for treating Hunter syndrome according to  claim 1 , wherein the first composition is injected at an effective dose of 0.1 mg/kg to 5 mg/kg per week. 
     
     
         10 . The formulation for treating Hunter syndrome according to  claim 1 , wherein the second composition is injected at an effective dose of 0.1 mg/kg to 40 mg/kg per week. 
     
     
         11 . The formulation for treating Hunter syndrome according to  claim 1 , wherein the second composition is injected at an effective dose of 0.2 mg/kg to 10 mg/kg per week. 
     
     
         12 . The formulation for treating Hunter syndrome according to  claim 1 , wherein the second composition comprises at least one buffer selected from the group consisting of sodium phosphate and L-histidine. 
     
     
         13 . The formulation for treating Hunter syndrome according to  claim 1 , wherein the second composition comprises at least one stabilizer selected from the group consisting of Polysorbate 20 and arginine. 
     
     
         14 . The formulation for treating Hunter syndrome according to  claim 1 , wherein the second composition comprises an absorption enhancer, which is hyaluronidase. 
     
     
         15 . A formulation for treating Hunter syndrome, comprising a therapeutic composition subcutaneously administered to a patient at a dose of 0.001 mL/hour to 100 mL/hour.