Saphnelo (anifrolumab-fnia) is a fully human monoclonal antibody that binds to subunit 1 of the type I interferon (IFN) receptor, blocking the activity of all type I IFNs. It is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.
Emerging Technology Reports
The Emerging Technology Report provides regular updates about emerging and potentially disruptive technologies that are likely to have a significant impact in healthcare. This “early warning” report monitors new health technologies from 6 months to 2 years within a regulatory submission and tracks those as they go through clinical trial development and the regulatory approval process.
For each emerging technology, our analysts describe the technology and intended use, its prospects relative to the regulatory process and FDA information, competing technologies, relevant clinical guidelines, high-level look at the evidence such as published abstracts in the medical literature and available meeting abstracts, and available clinical trials.
The OCS Liver is a portable extracorporeal liver perfusion and monitoring system under investigation for the resuscitation, preservation, and assessment of liver allografts from donors after brain death or liver allografts from donors after circulatory death ≤ 55 years old in a near-physiologic, normothermic, and functioning state intended for a potential transplant recipient…
Retifanlimab is an investigational intravenous humanized monoclonal antibody that inhibits the activity of programmed death-1 (PD-1). By blocking PD-1, retifanlimab acts as an immune checkpoint inhibitor, freeing T cells to kill cancer cells and boosting immune system response against certain cancers. Retifanlimab is proposed as a monotherapy for locally advanced and metastat…
Efgartifimod is an investigational, intravenously administered neonatal Fc receptor antagonist in development for the treatment of generalized myasthenia gravis.
Tezepelumab is an investigational, subcutaneously injected, human monoclonal antibody that inhibits thymic stromal lymphopoietin. It is proposed for treatment of patients with severe, uncontrolled asthma.
Oleogel-S10 is a semisolid gel containing 10% betulin-rich extract from birch bark and 90% refined sunflower oil. Betulin is a naturally occurring triterpene with medicinal properties believed to help modulate the inflammation response and encourage formation of new skin during wound healing. It is in development for the treatment of skin wounds associated with epidermolysis …
Kerendia (finerenone) is a nonsteroidal mineralocorticoid receptor antagonist indicated to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease associated with type 2 diabetes.
Aduhelm (aducanumab) is an intravenously administered amyloid beta-directed antibody for the treatment of Alzheimer disease.
Avacopan is an oral complement component 5a (C5a) antagonist for treatment of adult patients with anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV).
Teplizumab is an intravenously administered anti-CD3 monoclonal antibody in development for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.