Tezepelumab is under clinical development by Amgen 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 Tezepelumab’s likelihood of approval (LoA) and phase transition for Cat Allergy took place on 05 Dec 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.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Tezepelumab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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, chronic obstructive pulmonary disease, eosinophilic esophagitis 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 six focused disease areas including cardiovascular diseases, oncology/hematology, inflammation, bone health, neurological disorders and nephrology. The company develops products using advanced human genetics to unravel 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 such as print, television and online media. Amgen is headquartered in Thousand Oaks, California, the US.

Quick View Tezepelumab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Tezepelumab
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Dermatology
  • Ear Nose Throat Disorders
  • Gastrointestinal
  • Immunology
  • Respiratory
Key Developers
Highest Development Stage
  • Marketed

GlobalData

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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.