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.

Interferon gamma-1b overview

Human interferon gamma-1b (Actimmune, Immukin, Imukin) an interferon-gamma, is a single-chain polypeptide containing 140 amino acids produced by recombinant DNA technology. It is formulated as an injection for subcutaneous route of administration. It is indicated for the reduction of the frequency of serious infections in patients with chronic granulomatous disease (CGD) and for the reduction in the frequency of serious infections in patients with severe, malignant osteopetrosis. It is indicated for chronic granulomatous disease (CGD) in adults and children. The drug candidate is believed to stimulate the immune system to respond to injury or infection. It is a bio-engineered form of interferon gamma which is produced by genetically engineered E.coli bacterium containing the DNA which encodes for the human protein.

It is under development for the treatment of relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome, autosomal dominant intermediate osteopetrosis type II (ADO2). The drug candidate was also under development for the treatment of idiopathic pulmonary fibrosis, non-small cell lung cancer, small cell lung cancer, triple-negative breast cancer (TNBC), Friedreich ataxia, chondrosarcoma, cystic fibrosis, malignant mesothelioma, cirrhosis, ovarian cancer, uterine sarcoma, olid tumors including urothelial bladder cancer, melanoma,  head and neck cancer squamous cell carcinoma, gastric cancer, colon cancer, hepatocellular carcinoma,  gastrointestinal stromal tumor, endometrial cancer, liposarcoma and liver fibrosis. The drug candidate is a cytotoxic and immunomodulator agent. It is formulated as an injection for subcutaneous administration. The inhalation drug formulation was under development for the treatment of Mycobacterium avium complex infection and renal cell carcinoma.

Amgen overview

Amgen is a biotechnology company, which discovers, develops, manufactures, and markets innovative human medicines to treat patients suffering from serious diseases. It develops novel medicines for the treatment of cardiovascular conditions, oncology/hematology, inflammation, bone health, neurological disorders and nephrology conditions. The company analyzes the difficulties of disease and understands the fundamentals of human biology to develop products harnessing advanced human genetics. Amgen sells products primarily to pharmaceutical wholesale distributors in the US. It also markets certain products directly to consumers through direct-to-consumer channels and through partnerships with other companies. The company has a presence in Asia Pacific, Europe, the Middle East, the Americas and Australia. Amgen is headquartered in Thousand Oaks, California, the US.

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

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.