Nipocalimab is under clinical development by Johnson & Johnson and currently in Phase III for Erythroblastosis Fetalis (Hemolytic Disease In Newborns). According to GlobalData, Phase III drugs for Erythroblastosis Fetalis (Hemolytic Disease In Newborns) does not have sufficient historical data to build an indication benchmark PTSR for Phase III. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Nipocalimab LoA Report. 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.

Nipocalimab overview

Nipocalimab (M-281) is under development for the treatment of moderate to severe bullous pemphigoid (BP), moderate to severe active rheumatoid arthritis (RA), chronic inflammatory demyelinating polyneuropathy (CIDP), fetal and neonatal alloimmune thrombocytopenia (FNAIT), systemic lupus erythematosus, immune-mediated necrotizing myopathy, erythroblastosis fetalis (hemolytic disease of the fetus and newborn (HDFN)), generalized myasthenia gravis, idiopathic inflammatory myopathies, lupus nephritis, primary Sjogren’s syndrome (pSS) and warm autoimmune hemolytic anemia. It is administered through intravenous and subcutaneous routes which is formulated as a concentrate solution. The drug candidate acts by targeting neonatal Fc receptor ((FcRn). It is a new molecular entity (NME).

It was also under development for the treatment of idiopathic thrombocytopenia purpura and rheumatoid arthritis.

Johnson & Johnson overview

Johnson & Johnson (J&J) researches, develops, manufactures, and sells pharmaceutical products and medical devices. The company conducts business through its operating companies. It provides pharmaceuticals for immune disorders, cancer, neurological disorders, infectious, cardiovascular, and metabolic diseases; and medical devices for use in cardiovascular, orthopaedic, neurovascular care, general surgery and vision care fields. J&J distributes pharmaceutical and medical products to retailers, wholesalers, healthcare professionals and hospitals. The company offers its products in the US; Europe; Asia-Pacific and Africa; and Western Hemisphere (excluding the US) and Latin America. J&J is headquartered in New Brunswick, New Jersey, the US.

For a complete picture of Nipocalimab’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.