C1 esterase inhibitor (human) is under clinical development by Takeda Pharmaceutical and currently in Phase II for Acquired (Autoimmune) Hemolytic Anemia. According to GlobalData, Phase II drugs for Acquired (Autoimmune) Hemolytic Anemia have a 62% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how C1 esterase inhibitor (human)’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
C1 esterase inhibitor (human) overview
C1 esterase inhibitor (Cinryze, SHP616) is a sterile, lyophilized preparation derived from human plasma. Cinryze is formulated as powder for solution for intravenous route of administration. Cinryze is indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE). It is also used for routine prevention of angioedema attacks in children (ages 6 years and above) with severe and recurrent attacks of HAE.
It is under development for the treatment of traumatic brain injury, aneurysmal subarachnoid hemorrhage and autoimmune hemolytic anemia (AIHA). It was under development for the treatment of acute antibody-mediated rejection in recipients of donor-sensitized kidney transplants, paroxysmal nocturnal hemoglobinuria, hereditary angioedema (EU) and neuromyelitis optica.
Takeda Pharmaceutical overview
Takeda Pharmaceutical (Takeda) is a global pharmaceutical company primarily engaged in the research, development, production, and commercialization of biopharmaceutical products. It provides treatment for inflammatory bowel disease, acid-related diseases, motility disorders and liver diseases; hemophilia and hereditary bleeding disorders; primary immunodeficiency and multifocal motor neuropathy; major depressive disorder and attention-deficit hyperactivity disorder; and its cancer treatment encompasses multiple myeloma, mantle cell lymphoma, non-small cell lung cancer and chronic myeloid leukemia. While the company markets its pharmaceutical products directly, it also collaborates with marketing alliance partners in worldwide. Takeda operates in various countries worldwide, including Japan, the US, Europe, Latin America, Africa, the Middle East, and the Asia Pacific region. Takeda is headquartered in Tokyo, Japan.
For a complete picture of C1 esterase inhibitor (human)’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
