Anifrolumab is under clinical development by AstraZeneca and currently in Phase III for Systemic Sclerosis (Scleroderma). According to GlobalData, Phase III drugs for Systemic Sclerosis (Scleroderma) have a 40% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Anifrolumab’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.

Anifrolumab overview

Anifrolumab (Saphnelo) is a immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that is produced in mouse myeloma cells (NS0) by recombinant DNA technology. It is formulated as solution, concentration solution for intravenous route of administration. Saphnelo is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.

Anifrolumab (MEDI-546) is under development for the treatment of systemic lupus erythematosus, scleroderma, polymyositis, idiopathic inflammatory myopathies, primary Sjogren''s syndrome, vitiligo, chronic and/or subacute cutaneous lupus erythematosus and active proliferative lupus nephritis. The drug candidate is administered through intravenous and subcutaneous route as a solution. It is a fully human monoclonal antibody. It targets IFN-alpha receptor subunit 1 (IFNAR1). The drug candidate is based on UltiMAb Human antibody development technology platform. It was also under development for rheumatoid arthritis.

AstraZeneca overview

AstraZeneca is a biopharmaceutical company, which is focused on discovery, production and commercialization of a range of prescription drugs. It develops products related to therapy areas such as respiratory, cardiovascular, renal and metabolic diseases, cancer, autoimmune, infection and neurological diseases. The company’s product portfolio includes biologics, prescription pharmaceuticals and vaccines. AstraZeneca sells its products through wholly- owned local marketing companies, distributors and local representative offices. The company markets its products to primary care and specialty care physicians. The company operates in Europe, the Americas, Asia, Africa and Australasia. AstraZeneca is headquartered in Cambridge, Cambridgeshire, the UK.

For a complete picture of Anifrolumab’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.