IP Library › Patent Application 17378200
Patent Application
App. No. 17/378,200

METHODS OF USING FIX POLYPEPTIDES

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Quick Facts
Patent No.
US None
App. No.
17/378,200
Abstract

The present invention provides methods of administering long-acting Factor IX; methods of administering long-acting, chimeric and hybrid polypeptides comprising Factor IX; and methods of producing such chimeric and hybrid polypeptides using cells.

Claims (26)

1 - 130 . (canceled)

131 . A method of reducing or decreasing an annualized bleeding rate in a human subject with hemophilia B, comprising administering to the subject multiple doses of a pharmaceutical composition comprising:

(a) a chimeric Factor IX(FIX) polypeptide comprising human FIX and an FcRn binding partner;

(b) sucrose;

(c) mannitol; and

(d) polysorbate 20 or polysorbate 80,

wherein each of the multiple doses comprises 10 IU/kg to 200 IU/kg of the chimeric FIX polypeptide wherein each of the multiple doses is administered at a dosing interval of about 7 days to about 14 days, wherein the annualized bleeding rate of the bleeding episodes is reduced to less than 5; and wherein the bleeding episodes are spontaneous bleeding episodes.

132 . The method of claim 131 , wherein the pharmaceutical composition comprises polysorbate 80.

133 . The method of claim 131 , wherein each of the multiple doses of the chimeric FIX polypeptide is 50 IU/kg to 100 IU/kg.

134 . The method of claim 131 , wherein each of the multiple doses of the chimeric FIX polypeptide is 100 IU/kg.

135 . The method of claim 131 , wherein each of the multiple doses is about 50 IU/kg or about 100 IU/kg and the dosing interval is about 10 days to about 14 days.

136 . The method of claim 135 , wherein the annualized bleeding rate of the spontaneous bleeding episodes is reduced to less than 4.

137 . The method of claim 135 , wherein the annualized bleeding rate of the spontaneous bleeding episodes is reduced to less than 3.

138 . The method of claim 135 , wherein the annualized bleeding rate of the spontaneous bleeding episodes is reduced to less than 2.

139 . The method of claim 131 , wherein each of the multiple doses is for individualized interval prophylaxis of one or more spontaneous bleeding episodes.

140 . The method of claim 139 , wherein the annualized bleeding rate of the one or more spontaneous bleeding episodes is reduced to less than 4.

141 . The method of claim 131 , wherein the dosing interval is every 7 days to 14 days.

142 . The method of claim 131 , wherein each of the multiple doses is about 25 IU/kg to about 50 IU/kg and the dosing interval is about 7 days.

143 . The method of claim 142 , wherein the annualized bleeding rate of the spontaneous bleeding episodes is reduced to less than 4.

144 . The method of claim 142 , wherein the annualized bleeding rate of the spontaneous bleeding episodes is reduced to less than 3.

145 . The method of claim 142 , wherein the annualized bleeding rate of the spontaneous bleeding episodes is reduced to less than 2.

146 . The method of claim 131 , wherein the annualized bleeding rate of the spontaneous bleeding episodes is reduced to less than 1.

147 . The method of claim 131 , wherein each of the multiple doses is 25 IU/kg to 50 IU/kg.

148 . The method of claim 131 , wherein the human FIX comprises amino acids 1 to 415 of SEQ ID NO: 2.

149 . The method of claim 148 , wherein each of the multiple doses is about 50 IU/kg and the dosing interval is about 7 days.

150 . The method of claim 148 , wherein each of the multiple doses is about 100 IU/kg and the dosing interval is about 10 days.