Anakinra is under clinical development by Swedish Orphan Biovitrum 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 Anakinra’s likelihood of approval (LoA) and phase transition for Myocarditis took place on 16 Jun 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 Anakinra Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Anakinra overview

Anakinra (Kineret) is an immunosuppressant produced in Escherichia coli cells by recombinant DNA technology. It is formulated as a solution for subcutaneous route of administration. Kineret is indicated in adults for the treatment of the signs and symptoms of Rheumatoid Arthritis (RA) in combination with methotrexate, with an inadequate response to methotrexate alone, in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including: Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA), Muckle-Wells Syndrome (MWS), Familial Cold Autoinflammatory Syndrome (FCAS).Kineret is indicated for the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA). Kineret is indicated for the treatment of coronavirus disease (COVID-19) in adult patients with pneumonia requiring supplemental oxygen. 

Anakinra is under development for the treatment of sepsis, pancreatic ductal adenocarcinoma (PDAC), chronic lymphocytic leukemia (CLL), mucopolysaccharidosis III, bladder pain syndrome, autoimmune inner ear disease, acute myocarditis, intracerebral hemorrhage, cystitis and COVID-19 pneumonia. It is also under development for treatment of hyper-inflammatory syndrome, complications associated with COVID-19 disease. It is administered through subcutaneous, intravenous and periarticular routes. It was under development for metastatic adenocarcinoma of the pancreas, mucocutaneous lymph node syndrome (Kawasaki Disease), hidradenitis suppurativa, systemic-onset juvenile idiopathic arthritis (Still Disease), acute gout, hospital acquired pneumonia, community acquired pneumonia and metastatic breast cancer. It is administered through intravenous drip and intravenous bolus route.

It was under development for the treatment of traumatic brain injury and ulcerative colitis.

Swedish Orphan Biovitrum overview

Swedish Orphan Biovitrum (Sobi) is an integrated biopharmaceutical company. It focuses on the development of products for the treatment of a few rare diseases. The company specializes in biotechnology with prime capabilities in protein biochemistry and biologics manufacturing. Its product portfolio focuses on hemophilia, immunology, specialty care, inflammation and genetic and metabolic diseases. The company also provides innovative treatment for conditions such as amyotrophic lateral sclerosis (ALS) and Hemophilia A. Sobi also manufactures and markets specialty products for rare diseases for partner companies. The company has operational presence in Europe, the Middle East, North America, Russia, and Asia. Sobi is headquartered in Stockholm, Sweden.

Quick View Anakinra LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Anakinra
Administration Pathway
  • Intravenous
  • Intravenous Bolus
  • Intravenous Drip
  • Periarticular
  • Subcutaneous
Therapeutic Areas
  • Cardiovascular
  • Central Nervous System
  • Dermatology
  • Ear Nose Throat Disorders
  • Gastrointestinal
  • Genetic Disorders
  • Genito Urinary System And Sex Hormones
  • Immunology
  • Infectious Disease
  • Metabolic Disorders
  • Musculoskeletal Disorders
  • Oncology
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.