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.
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.
Vivistim Paired VNS System for Stroke Rehabilitation
The Vivistim Paired VNS System is an implanted neurostimulator system intended to be used to stimulate the vagus nerve during rehabilitation therapy in order to reduce upper extremity motor deficits and improve motor function in chronic ischemic stroke patients with moderate to severe arm impairment.
Oportuzumab Monatox for Non-muscle Invasive Bladder Cancer
Oportuzumab monatox is an antibody-drug conjugate that targets epithelial cell-adhesion molecule (EpCAM) in development for the treatment of bacillus Calmette-Guerin-unresponsive non-muscle invasive bladder cancer. It is an intravesical treatment, administered through a catheter directly into the bladder.
Viveve System for Stress Urinary Incontinence in Women
The Viveve System is a cryogen-cooled monopolar radiofrequency device proposed for treatment of stress urinary incontinence in premenopausal women.
Saphnelo (Anifrolumab-fnia) for Systemic Lupus Erythematosus
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.
Retifanlimab for Squamous Cell Anal Cancer
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…
Ryplazim (Plasminogen, Human-tmvh) for Plasminogen Deficiency Type 1
Ryplazim is plasma-derived human plasminogen indicated for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia). Ryplazim is recovered from healthy donor plasma; plasminogen is extracted using a proprietary process. Purified isolated plasminogen is administered by intravenous infusion.
Lumakras (Sotorasib) for Non-Small Cell Lung Cancer
Lumakras (sotorasib) is an oral KRAS G12C inhibitor designed to block the abnormal proliferative action of mutant KRAS protein. It is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who hav…
IpsiHand Upper Extremity Rehabilitation System
The IpsiHand Upper Extremity Rehabilitation System is a brain-computer-interface/robotic arm exoskeleton system for use in chronic stroke patients (≥ 6 months post-stroke) aged ≥ 18 years undergoing stroke rehabilitation, to facilitate muscle re-education and for maintaining or increasing range of motion in the upper extremity.
Breyanzi (Lisocabtagene Maraleucel) for Large B-Cell Lymphoma
Breyanzi (lisocabtagene maraleucel [liso-cel]) is an autologous chimeric antigen receptor (CAR) T-cell therapy, a novel type of immunotherapy in which a patient’s own immune cells are genetically re-programmed to target and attack cancer cells. It is indicated for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after 2 or more lines of …