Baxter, a blood disease giant, submitted a long-term regulatory application for advanced to FDA

December 2, 2014 / BIOON / -- Baxter International, a blood disease giant, recently announced that it has submitted Bax 855's biological product license application (BLA) to the FDA Bax 855 is a kind of recombinant coagulation factor VIII (rFVIII) with long half-life, which is developed on the basis of Advate It is developed for the treatment of type a blood diseases Advate is the leading product of Baite, which has been on the market for more than 10 years It is the FVII product with the largest prescription volume in the world Bax 855 is a long-term version of advance If approved, Bax 855 will become an important new treatment option for patients aged 12 and over with hemophilia A Bax 855 BLA was submitted based on the results of a prospective global phase III clinical trial The study was conducted in 137 patients with hemophilia A who had previously been treated The data showed that Bax 855 reached the main end point of controlling and preventing bleeding events and daily prevention Compared with on-demand treatment, the average annual bleeding rate was reduced by 95% when the preventive treatment was injected every two weeks Baite plans to submit more data on key clinical trials of Bax 855 in the next few months Once the paediatric clinical trial is completed, Baite is expected to submit a marketing approval application (MAA) for Bax 855 to the European Drug Administration (EMA) in 2016 Bax 855 is an enhanced version of advocate, a leading blood disease drug Advate is a full-length recombinant FVII product without any blood additives It is suitable for the treatment and prevention of haemorrhage in patients with type a hemophilia, and not suitable for the treatment of von Willebrand disease (VWD) It has been approved by 64 countries in the world Bax 855 uses the proprietary PEGylation technology to extend the activity duration of the protein in vivo The proprietary technology has been applied to a variety of marketed drugs Hemophilia type A, also known as typical hemophilia, is a genetic disease caused by the lack of clotting factor VIII or protein defect of clotting factor VIII In June this year, the FDA approved eloctate, a long-acting hemophilia drug produced by its potential competitor Biogen Idec, the first recombinant coagulation factor VIII product with extended circulation half-life The indications of the drug are: control and prevention of haemorrhagic events in children and adults with hemophilia A, perioperative management and routine prevention (related reading: elictate, a new hemophilia drug of Baijian Edie, was approved by FDA) at the end of October this year, the franchise of Baite hemophilia was further expanded, and the new drug obizur was approved by FDA for the treatment of adult patients with acquired hemophilia A (AHA) Obizur is the first recombinant porcine coagulation factor VIII (FVII) product approved by FDA for AHA treatment AHA is a rare acute haemorrhagic disease with a incidence rate of one in a million Original English: Baxter submissions application for U.S FDA approval of Bax 855, extended half life recombiner FVII based on advanced for hemophelia a twice weekly proactive register resulting in 95% reduction in medical annualized blind rate compared to on demand treatment deierfield, ill., December 1, 2014 - Baxter International Inc (NYSE:BAX) today announced that the company has submitted a biologics license application (BLA) to the United States Food and Drug Administration (FDA) for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)] "The evidence from our late-stage controlled trial showcases that BAX 855 could become an important new treatment option for people with hemophilia A, expanding on more than a decade of experience with ADVATE, " said John Orloff, M.D., vice president and global head of research and development for Baxter BioScience "BAX 855 represents our continued commitment to developing valuable new options for the hemophilia community that address the needs of patients around the world." The submission is based on positive results from a prospective, global, multi-center, open-label, two-arm Phase 3 study of 137 previously treated patients (PTP) The results demonstrated that BAX 855 met its primary endpoint in the control and prevention of bleeding episodes and routine prophylaxis for patients who were 12 years or older Patients in a twice-weekly prophylaxis arm experienced a 95 percent reduction in median ABR as compared to those in the on-demand arm (1.9 vs 41.5, respectively) BAX 855 was also effective in treating bleeding episodes, 96 percent of which were controlled with one or two infusions No patients developed inhibitors to BAX 855 and no treatment-related serious adverse events, including hypersensitivity, were reported The most common (three patients) product-related adverse reaction was headache Baxter expects to present additional data from the BAX 855 pivotal trial in the coming months The continuation study remains ongoing for patients who completed the pivotal trial and the Phase 3 study among previously treated patients under the age of 12 with severe hemophilia A is progressing Once the pediatric study is complete, Baxter expects to file for marketing authorization with the European Medicines Agency in 2016 Upon approval, BAX 855 is expected to be produced at the company's Singapore manufacturing facility, one of several sites currently approved for ADVATE production BAX 855 is based on ADVATE, a full-length FVIII molecule with more than 10 years of real-world experience Through a collaboration with Nektar Therapeutics (NASDAQ: NKTR), BAX 855 leverages proprietary PEGylation technology designed to extend the duration of activity of proteins in the body This proprietary technology has been used for over 10 years in a number of approved medicines that treat chronic or serious conditions About ADVATE ADVATE is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency or classic hemophilia) for: Control and prevention of bleeding episodes Perioperative management Routine prophylaxis to prevent or reduce the frequency of bleeding episodes ADVATE is not indicated for the treatment of von Willebrand disease ADVATE has a demonstrated efficacy and safety profile ADVATE is a full-length (derived from the complete FVIII gene) recombinant FVIII product that is processed without any blood-based additives Because no blood-derived components are added at any stage of the manufacturing process, the potential risk of transmitting pathogens that may be carried in blood-based additives is eliminated There have been no confirmed reports of transmission of HIV, HBV or HCV with rFVIII treatments ADVATE is the world's most prescribed FVIII treatment It is currently approved in 64 countries worldwide, including the United States, Canada, 28 countries in the European Union, Algeria, Argentina, Australia, Brazil, Chile, China, Colombia, Ecuador, Hong Kong, Iceland, Iraq, Israel, Japan, Kuwait, Macau, Malaysia, Mexico, Morocco, New Zealand, Norway, Panama, Puerto Rico, Russia, Saudi Arabia, Serbia, Singapore, South Korea, Suriname, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, Uruguay, and Venezuela.