Emapalumab is under clinical development by Swedish Orphan Biovitrum and currently in Phase III for Systemic-Onset Juvenile Idiopathic Arthritis (Still Disease). According to GlobalData, Phase III drugs for Systemic-Onset Juvenile Idiopathic Arthritis (Still Disease) have an 89% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Emapalumab’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.

Emapalumab overview

Emapalumab (Gamifant) is a monoclonal antibody, acts as an immunosuppressant. It is formulated as injectable solution for intravenous route of administration. Gamifant is indicated for the treatment of primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance to conventional hemophagocytic lymphohistiocytosis therapy in pediatric (new born and older) and adult patients.

Emapalumab (NI-0501, Gamifant) is under development for the treatment of macrophage activation syndrome (MAS) in Still's disease (including systemic juvenile idiopathic arthritis and adult onset Still's disease (AOSD)) and systemic lupus erythematosus (SLE), auto-immune and inflammatory diseases such as secondary hemophagocytic lymphohistiocytosis (HLH) and hyper-inflammatory syndrome, a complications associated with severe COVID-19 disease and It is administered intravenously. The drug candidate acts by targeting interferon gamma. It was under development for the treatment of primary HLH.

Emapalumab was under development for prevention of graft failure following hematopoietic stem cell transplantation and Graft failure.

Swedish Orphan Biovitrum overview

Swedish Orphan Biovitrum (Sobi) is an integrated biopharmaceutical company. It focuses on the development of products for the treatment of a few rare diseases. The company specializes in biotechnology with prime capabilities in protein biochemistry and biologics manufacturing. Its product portfolio focuses on hemophilia, immunology, specialty care, inflammation, and genetic and metabolic diseases. The company also provides innovative treatment for conditions such as amyotrophic lateral sclerosis (ALS). Sobi also manufactures and markets specialty products for rare diseases for partner companies. The company has operational presence in Europe, the Middle East, North America, Russia, and Asia. Sobi is headquartered in Stockholm, Sweden.

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

This content was updated on 2 September 2023

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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.