Immune globulin (human) is under clinical development by Octapharma and currently in Phase III for Systemic Lupus Erythematosus. According to GlobalData, Phase III drugs for Systemic Lupus Erythematosus have a 33% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Immune globulin (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.
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.
The drug candidate is under development for the treatment of mild cognitive impairment and chronic inflammatory demyelinating polyneuropathy (CIDP), pediatric acute-onset neuropsychiatric syndrome, systemic lupus erythematosus, Tourette disorder, obsessive-compulsive disorder. and coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It was also under development for treatment of stiff-person syndrome, Alzheimer's disease, Guillain-Barre syndrome, relapsing remitting multiple sclerosis (RRMS) and Rasmussen’s encephalitis.
Octapharma is a human protein product manufacturer that focuses on developing and producing medicines through human proteins from human plasma and cell lines. The company treats patients worldwide with products across immunotherapy, hematology, and critical care therapeutic areas. It 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. The company’s 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.