Tezepelumab by Amgen for Chronic Obstructive Pulmonary Disease (COPD): Likelihood of Approval

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.

Tezepelumab overview

Tezepelumab-ekko (Tezspire) is a first-in-class human monoclonal antibody immunoglobulin G2λ (IgG2λ) produced by recombinant DNA technology. It is formulated as solution for subcutaneous route of administration. Tezspire is indicated for the add-on maintenance treatment of adults, adolescents and pediatric patients aged 12 years and older with severe asthma.

Tezepelumab (AMG-157, MEDI-9929) is under development for the treatment of severe chronic rhinosinusitis with nasal polyposis, chronic spontaneous urticaria, severe uncontrolled asthma, churg-strauss syndrome (eosinophilic granulomatosis with polyangiitis), chronic obstructive pulmonary disease, eosinophilic esophagitis, peanut allergy and cat allergy. The therapeutic candidate is administered intravenously and subcutaneously in the form of suspension and solution. AMG-157 is a fully human monoclonal antibody targeting the interaction of thymic stromal lymphopoietin (TSLP) with TSLP receptors. It was also under development for allergic asthma and atopic dermatitis.

Amgen overview

Amgen is a biotechnology company, which discovers, develops, manufactures, and markets innovative human medicines to treat patients suffering from serious diseases. It develops novel medicines in therapeutic areas of cardiovascular, oncology/hematology, inflammation, bone health, neurological disorders and nephrology. The company develops products using advanced human genetics to analyze the difficulties of disease and understand the fundamentals of human biology. Amgen sells products primarily to pharmaceutical wholesale distributors in the US. It also markets certain products directly to consumers through direct-to-consumer channels and through partnerships with other companies. The company has presence in Asia Pacific, Europe, Middle East, North America and Australia. Amgen is headquartered in Thousand Oaks, California, the US.

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

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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.