Baxalta now part of Shire

Quick facts

Marketed products

• Alpha1-Proteinase Inhibitor · Pulmonology / Respiratory
  Alpha1-proteinase inhibitor (AAT) replaces deficient or dysfunctional alpha-1 antitrypsin protein to protect lung tissue from enzymatic degradation.
• ARALAST Alpha1-Proteinase Inhibitor
• CUVITRU · Immunology
• ITI · Hematology
  ITI is an immune tolerance induction therapy that uses a combination of immunosuppressive agents to induce tolerance to factor VIII in hemophilia A patients with inhibitors.
• KIOVIG · Other
• OBIZUR · Hematology
  OBIZUR is a recombinant human Factor VIII that replaces deficient or dysfunctional Factor VIII to restore blood clotting ability in patients with hemophilia A.
• Placebo: Human albumin 2.5% · Critical Care; Hematology
  Human albumin 2.5% acts as a volume expander and oncotic agent to maintain intravascular fluid balance and plasma colloid osmotic pressure.
• Recombinant factor IX · Hematology
  Recombinant factor IX replaces the missing or deficient clotting factor IX to restore the intrinsic coagulation pathway and enable normal blood clot formation.
• Recombinant Factor VIII (rAHF) · Hematology
  Recombinant Factor VIII replaces the missing or deficient clotting factor VIII protein to restore the intrinsic coagulation pathway and enable normal blood clot formation.
• RIXUBIS · Other
• RIXUBIS: On-Demand · Hematology
  RIXUBIS is a recombinant Factor IX that replaces deficient or dysfunctional clotting factor IX to restore blood coagulation in patients with hemophilia B.
• RIXUBIS: Prophylaxis · Hematology
  Rixubis is a recombinant Factor IX (prothrombin complex component) that replaces deficient clotting factor to restore the intrinsic coagulation pathway.

Phase 3 pipeline

• BAX 326 · Hematology
  BAX 326 is a recombinant human coagulation factor VIII designed to treat hemophilia A by replacing deficient or dysfunctional factor VIII.
• BAX855 · Hematology
  BAX855 is a recombinant factor VIII (antihemophilic factor) fused to the Fc portion of human immunoglobulin G1 to extend half-life and improve hemostasis in hemophilia A.
• IGIV GAMMAGARD LIQUID/KIOVIG · Immunology
  IGIV (intravenous immunoglobulin) provides passive immunity by supplying pooled human antibodies to replace or supplement deficient or dysfunctional immunoglobulin in patients with immune deficiencies or autoimmune conditions.
• IGIV GAMUNEX®-C · Immunology
  IGIV Gamunex-C is an intravenous immunoglobulin (IVIG) that provides passive immunity by supplying pooled human antibodies to help patients fight infections and modulate immune responses.
• IV treatment with IGSC, 10% · Immunology
  IGSC 10% is an intravenous immunoglobulin (IVIG) preparation that provides passive immunity by supplying pooled human antibodies to help regulate immune function and fight infections.
• PEGylated Recombinant Factor VIII · Hemophilia A
  PEGylated Recombinant Factor VIII is a recombinant form of human factor VIII that is modified with polyethylene glycol (PEG) to prolong its half-life.
• rVWF

Phase 2 pipeline

• ADYNOVI · Hematology
  ADYNOVI is a recombinant human coagulation factor VIII, used to treat and prevent bleeding episodes in patients with hemophilia A.
• BAX326 · Oncology
  BAX326 is a monoclonal antibody targeting CD19.
• rAHF-PFM

Phase 1 pipeline

• Aerosolized, Recombinant Alpha 1-Antitrypsin
• AskBio009
• BAX 826
• BAX 888

Competitive intelligence

For the full portfolio CI brief — phase mix, recent regulatory actions, upcoming PDUFA dates, patent timeline, class-overlap with competitors:

• Baxalta now part of Shire portfolio CI brief
• Baxalta now part of Shire pipeline updates RSS

Frequently asked questions about Baxalta now part of Shire

Related

• Alpha1-Proteinase Inhibitor · Pulmonology / Respiratory
• ARALAST Alpha1-Proteinase Inhibitor
• CUVITRU · Immunology
• ITI · Hematology
• KIOVIG · Other
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