Method of Administering Porcine B-Domainless fVIII

摘要

The present invention provides a method of administering porcine B-domainless factor VIII (OBI-1) to a patient having factor VIII deficiency to provide more rapid and effective protection against bleeding episodes, compared to formerly available methods, or to provide more effective protection to such patients during non-bleeding periods. This invention is based on the discovery that the recombinant B-domainless porcine fVIII, termed OBI-1, has greater bioavailability compared to the natural porcine fVIII partially purified from porcine plasma, termed HYATE:C. Therefore, the inventive method employs lower unit doses of OBI-1, including, alternatively, omission of antibody-neutralizing dosage, or has longer intervals between the administration, compared to HYATE:C, to provide equivalent protection in patients having fVIII deficiency. The invention further provides pharmaceutical compositions and kits containing OBI-1 in combination with a pharmaceutically acceptable carrier, that are useful for treating patients in need of fVIII more effectively.

主权项

1. A solid pharmaceutical composition obtainable by lyophilization of a solution comprising OBI-1, wherein the OBI-1 is a product of expression of a nucleic acid molecule encoding SEQ ID NO:2, a surfactant, calcium chloride, sucrose, sodium chloride and trisodium citrate, wherein the solution is maintained at a pH of 6-8 using a buffering agent prior to lyophilization and after reconstitution in water for injection, and wherein the solution is devoid of amino acids.