Vyvgart (efgartigimod alfa-fcab) is a first-in-class intravenously administered neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
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.
Tezspire (Tezepelumab-ekko) for Severe Asthma
Tezspire (tezepelumab-ekko) is a thymic stromal lymphopoietin blocker human monoclonal antibody indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
Optilume Drug-Coated Balloon for Urethral Strictures
Optilume is drug-coated balloon indicated to treat patients with obstructive urinary symptoms associated with anterior urethral stricture. It is designed to be used in adult males with urethral strictures ≤ 3 cm in length.
Voxzogo (Vosoritide) for Achondroplasia
Vosoritide is a longer-acting C-type natriuretic peptide (CNP) analog that modulates activity of the fibroblast growth factor receptor 3 (FGFR3) by inhibiting a signaling pathway that mediates its effects, thereby stimulating endochondrial growth, resulting in enhanced growth velocity. It is indicated to increase linear growth in pediatric patients aged ≥ 5 years with achondr…
Livmarli (Maralixibat) for Cholestatic Pruritus in Alagille Syndrome (ALGS)
Livmarli (maralixibat) is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 1 year of age and older.
Susvimo (Ranibizumab) Ocular Implant for Neovascular Age-related Macular Degeneration
Susvimo (ranibizumab injection) is a refillable ocular implant containing the vascular endothelial growth factor (VEGF) inhibitor ranibizumab indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) who have previously responded to at least two intravitreal injections of a VEGF inhibitor.
Balstilimab for Cervical Cancer
Balstilimab is an investigational intravenous immunotherapy. It inhibits the activity of programmed death-1 (PD-1), an immune checkpoint protein that helps restrain the immune system. Balstilimab is proposed for the second-line treatment of advanced cervical cancer in patients with disease progression or who experience a relapse during or after chemotherapy.
Lungpacer Diaphragm Pacing Therapy System
The Lungpacer Diaphragm Pacing Therapy (DPT) system is a temporary, minimally invasive, transvenous phrenic nerve pacing system intended for treatment of patients on mechanical ventilation to facilitate weaning from the ventilator.
Tavneos (Avacopan) for Anti-neutrophil Cytoplasmic Autoantibody-associated Vasculitis
Tavneos (avacopan) is an oral complement 5a receptor (C5aR) antagonist indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids.
Tivdak (Tisotumab Vedotin-tftv) for Cervical Cancer
Tivdak (tisotumab vedotin-tftv) is an intravenously administered tissue factor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.