Benralizumab is under clinical development by Kyowa Kirin 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 Benralizumab’s likelihood of approval (LoA) and phase transition for Churg-Strauss Syndrome took place on 28 Nov 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 28 Nov 2022 decreased Benralizumab’s LoA and PTSR for Chronic Urticaria Or Hives, decreased LoA and PTSR for Gastritis, decreased LoA and PTSR for Gastroenteritis, decreased LoA and PTSR for Granulomatosis with Polyangiitis (Wegener’s Granulomatosis), decreased LoA and PTSR for Hypereosinophilic Syndrome, and decreased LoA and PTSR for Rhinosinusitis.

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

Benralizumab overview

Benralizumab (Fasenra) is a glyco-engineered monoclonal antibody, acts as an anti asthmatic agent. It is formulated as solution for subcutaneous route of administration. Fasenra is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

Benralizumab (MEDI-563, KHK4563, BIW-8405) is under development for the treatment of  non-cystic fibrosis, severe uncontrolled asthma, severe prednisone dependent eosinophilic asthma, exercise-induced bronchoconstriction,  eosinophilic gastritis, hypereosinophilic syndrome (HES), eosinophilic chronic rhinosinusitis, eosinophilic granulomatosis with polyangiitis (Churg-Strauss Syndrome), chronic obstructive pulmonary disease (COPD), severe nasal polyposis, bullous pemphigoid, gastroenteritis and chronic spontaneous urticaria (Chronic Urticaria Or Hives).

It was also under development for the treatment of atopic dermatitis, chronic obstructive pulmonary disease (COPD),eosinophilic esophagitis and bronchiectasis.

Kyowa Kirin overview

Kyowa Kirin, a subsidiary of Kirin Holdings Co Ltd, is a biotechnology company focused on research and development. It is involved in the discovery, development, production and commercialization of pharmaceuticals and biotechnology products. The company offers drugs in the areas of nephrology, oncology, immunology and allergy, central nervous system among others. Its development pipeline consists of various protein, antibody and small molecule formulations for the treatment of neutropenia, anemia, chronic idiopathic thrombocytopenic purpura, hypertension, angina pectoris, allergic rhinitis, epilepsy, behavioral or personality disorders and others. The company operates through a network of subsidiaries in the US, Europe and Asia. Kyowa Kirin is headquartered in Tokyo, Japan.

Quick View Benralizumab LOA Data

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

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.