Immune globulin (human) is under clinical development by Octapharma and currently in Phase III for Unspecified Neurologic Disorders. According to GlobalData, Phase III drugs for Unspecified Neurologic Disorders does not have sufficient historical data to build an indication benchmark PTSR for Phase III. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Immune globulin (human) LoA Report. 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.
Immune globulin (human) overview
Human normal immunoglobulin (Octagam, Gamten, NewGam, Globiga, and Panzyga) is an immune sera preparation. Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents. It is formulated as injectable solution for intravenous route of administration. Human normal immunoglobulin is used for the treatment of primary immunodeficiency syndromes such as congenital agammaglobulinemia and hypogammaglobulinemia, severe combined immunodeficiencies, Wiskott Aldrich syndrome, chronic lymphatic leukemia with severe secondary hypogammaglobulinemia and recurrent infections and children with congenital AIDS who have repeated bacterial infections. Panzyga is indicated for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment.
Panzyga is under development for the treatment of small fiber neuropathy (SFN), chronic inflammatory demyelinating polyneuropathy (CIDP), pediatric acute-onset neuropsychiatric syndrome and naïve, relapsed or refractory chronic lymphocytic leukemia (CLL). It is administered through intravenous route.
Octapharma overview
Octapharma is a human protein product manufacturer. The company focuses on developing and producing medicines through human proteins from human plasma and cell lines. It treats patients worldwide with products across immunotherapy, hematology, and critical care therapeutic areas. The company sources plasma from company-owned plasma donation centers and other external sources. Octapharma owns plasma donation centers in the US and Germany and owns production facilities in Austria, Germany, France, Mexico, and Sweden. Its production plants carry out plasma fractionation and purification, pharmaceutical production, research and development, product labeling, packaging, storage, and distribution. Octapharma is headquartered in Lachen, Switzerland.
For a complete picture of Immune globulin (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.
