Budigalimab is under clinical development by AbbVie and currently in Phase III for Metastatic Hepatocellular Carcinoma (HCC). According to GlobalData, Phase III drugs for Metastatic Hepatocellular Carcinoma (HCC) have a 50% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Budigalimab’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.

Budigalimab overview

Budigalimab (ABBV-181) is under development for the treatment of Human immunodeficiency virus (HIV) infection, metastatic pancreatic adenocarcinoma, triple-negative breast cancer (TNBC), pancreatic adenocarcinoma, urothelial cancer, hepatocellular carcinoma (HCC), head and neck squamous cell carcinoma HNSCC (oral cavity, oropharynx, hypopharynx, and larynx) and metastatic or advanced endometrial carcinoma, hematological malignancies, HER2 negative breast cancer and solid tumors like small-cell lung cancer and non-small cell lung cancer. It is administered as an intravenous infusion and through subcutaneous route and targets programmed cell death protein 1 (PD1). It was also under development for epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer and metastatic colorectal cancer. It was also under development for the treatment of oral cavity (mouth) cancer; oropharyngeal cancer; laryngeal cancer; hypopharyngeal cancer.

AbbVie overview

AbbVie is a specialty biopharmaceutical company, which discovers, develops, manufactures, and commercializes drugs for the treatment of chronic and complex diseases. Its drugs are indicated for the treatment of metabolic and rheumatological diseases, neurological disorders, skin diseases, rheumatoid arthritis, pain related to endometriosis, pediatric Crohn’s disease, cancer, and other serious health conditions. AbbVie is also advancing its pipeline programs for the treatment of Crohn’s disease, Parkinson’s disease, neurological disorders, aesthetics, and other autoimmune diseases. The company markets its products directly to wholesalers, distributors, healthcare facilities, government agencies, specialty pharmacies, and independent retailers. The company has operations in the Americas, Asia-Pacific, Europe, the Middle East and Africa. AbbVie is headquartered in North Chicago, Illinois, the US.

For a complete picture of Budigalimab’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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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.