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.

Romosozumab overview

Romosozumab (Evenity) is a humanized monoclonal antibody. It is formulated as solution for subcutaneous route of administration. Evenity is indicated reduce the risk of fractures and increase bone mineral density in men and postmenopausal women with osteoporosis at high risk of fracture, and also indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy and for the treatment of osteoporosis in men at high risk of fracture to increase bone mass.

Romosozumab (Evenity, AMG-785, CDP-7851) is under development for treatment of bone-related conditions osteoporosis, postmenopausal osteoporosis and osteogenesis imperfecta. The drug candidate is a new biological entity (NBE). It is administered through subcutaneous route. AMG-785 is a humanized monoclonal antibody targeting sclerostin. It was also under development for osteopenia and fracture healing.

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 in therapeutic areas of cardiovascular, oncology/hematology, inflammation, bone health, neurological disorders and nephrology. The company develops products using advanced human genetics to analyze the difficulties of disease and understand the fundamentals of human biology. 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 presence in Asia Pacific, Europe, Middle East, North America and Australia. Amgen is headquartered in Thousand Oaks, California, the US.

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

This content was updated on 20 February 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.

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