Nipocalimab is under clinical development by Johnson & Johnson and currently in Phase III for Myasthenia Gravis. According to GlobalData, Phase III drugs for Myasthenia Gravis have a 70% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Nipocalimab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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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 and lupus nephritis. 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, primary Sjogren’s syndrome (pSS), warm autoimmune hemolytic anemia and rheumatoid arthritis.

Johnson & Johnson overview

Johnson & Johnson (J&J) researches, develops, manufactures, and sells pharmaceutical products, medical devices, and consumer products. The company provides pharmaceuticals for immune diseases, cancer, neurological disorders, infectious, cardiovascular, and metabolic diseases; consumer products in oral care, baby care, beauty, over the counter (OTC) medicines, women’s health and wound care categories; and medical devices for use in the cardiovascular, orthopaedic, neurovascular care, general surgery and vision care fields. J&J distributes pharmaceutical and medical products to retailers, wholesalers, health care professionals and hospitals; and offers consumer products through retail outlets and distributors. The company offers its products in the US; Europe; Asia-Pacific and Africa; and Western Hemisphere (excluding the US). 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 20 February 2024

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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.