Abatacept is under clinical development by Bristol-Myers Squibb and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.
According to GlobalData, the latest event to affect Abatacept’s likelihood of approval (LoA) and phase transition for Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) took place on 14 May 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.
In addition, the same event on 14 May 2022 decreased Abatacept’s Phase Transition Success Rate (PTSR) for Immunoglobulin G4-Related Disease (IgG4-RD), decreased LoA and PTSR for Interstitial Lung Diseases (Diffuse Parenchymal Lung Disease), and decreased LoA and PTSR for Polymyalgia Rheumatica (PMR).
GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Abatacept Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.
Abatacept (Orencia/ Ohrencia) is a soluble fusion protein produced by recombinant DNA technology in Chinese hamster ovary cells. It is formulated as an solution for subcutaneous route and powder for concentrate solution for intravenous route of administration. It is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis, for reducing signs and symptoms in pediatric patients 6 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis. It may be used as monotherapy or concomitantly with methotrexate (MTX), indicated for reducing signs and symptoms of juvenile rheumatoid arthritis in pediatric patients 6 years of age and older who have had an inadequate response to one or more DMARDs, such as MTX. Orencia in combination with methotrexate (MTX), for the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis (RA) not previously treated with MTX, indicated as alone or in combination with methotrexate for the treatment of active Psoriatic Arthritis (PsA) in adult patients for whom the response to previous disease-modifying antirheumatic drug (DMARD) therapy, including methotrexate, has been inadequate, and additional systemic therapy for psoriatic skin lesions is not required.
Abatacept is under development for the treatment of cytopenia, idiopathic inflammatory myopathy, polymyalgia rheumatica, interstitial lung diseases, Wegener's granulomatosis, immunoglobulin G4-related disease (IgG4-RD), graft versus host disease, COVID-19, myocarditis. It is administered through intravenous and subcutaneous routes. It acts by targeting CTLA 4.
It was also under development for the treatment of dermatomyositis, polymyositis, vitiligo, nephrotic syndrome including focal segmental glomerulosclerosis, uveitis, primary Sjogren's syndrome, psoriasis, alopecia areata, ulcerative colitis, Crohn's disease, sarcoidosis, giant cell arteritis, Takayasu arteritis, relapsing-remitting multiple sclerosis, chronic urticarial, untreated rheumatoid arthritis (intravenous), lupus nephritis (subcutaneous, intravenous), myasthenia gravis, systemic sclerosis, systemic lupus erythematosus and immune-mediated necrotizing myopathy
Bristol-Myers Squibb overview
Bristol-Myers Squibb (BMS) is a specialty biopharmaceutical company that is engaged in discovery, development, licensing and manufacturing, marketing, distribution and sale of medicines and related medical products to patients with serious diseases. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects. The company offers its products across the world to wholesalers, retail pharmacies, hospitals, medical professionals and government entities. BMS provides its products in the US, Europe, and Japan. The company conducts research to focus on the discovery and development of novel medicines that address serious diseases in areas of significant unmet medical need. BMS is headquartered in New York City, New York, the US.
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