Inebilizumab is an anti-CD19 monoclonal antibody. It was developed in response to the unmet treatment needs of patients with neuromyelitis optica spectrum disorder (NMOSD), a rare and debilitating autoimmune demyelinating disease that primary affects the optic nerves and spinal cord. Inebilizumab is administered every 6 months by intravenous infusion.
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.
Remestemcel-L for Acute Graft-Versus-Host Disease
Remestemcel-L is an allogeneic liquid cell suspension of ex-vivo cultured adult human mesenchymal stem cells derived from healthy donor bone marrow proposed for the treatment of pediatric patients with acute graft-versus-host-disease (aGVHD) refractory to standard first-line steroid therapy.
Remdesivir for COVID-19
Remdesivir is an investigational, intravenously administered antiviral agent proposed for treatment of COVID-19.
Satralizumab for Neuromyelitis Optica Spectrum Disorder
Satralizumab is an investigational anti-IL-6 receptor monoclonal antibody under FDA review for the treatment of neuromyelitis optica spectrum disorder in adults and adolescents. It is administered by subcutaneous injection.
Glu-Plasminogen (Proposed Name: Ryplazim) for Congenital Plasminogen Deficiency
Ryplazim is an investigational intravenous plasminogen replacement therapy for treatment of congenital plasminogen deficiency in children and adults. Ryplazim is recovered from healthy donor plasma; plasminogen is extracted using a proprietary process. Purified isolated plasminogen is administered by intravenous infusion.
Chloroquine and Hydroxychloroquine for COVID-19
Chloroquine (and its metabolite, hydroxychloroquine) is an oral 4-aminoquinoline antimalarial agent that has demonstrated antiviral effects on SARS-CoV and SARS-CoV-2 in vitro. It is being evaluated for the treatment of COVID-19.
Trodelvy (sacituzumab govitecan-hziy) for Metastatic Triple Negative Breast Cancer
Trodelvy (sacituzumab govitecan-hziy) is an intravenously administered antibody-drug conjugate (ADC) indicated for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least 2 prior therapies for metastatic disease. Trodelvy is the first FDA-approved ADC indicated for the treatment of TNBC.
Reblozyl (Luspatercept) for Beta Thalassemia
Reblozyl is an erythroid maturation agent administered via subcutaneous injection indicated for the treatment of patients with transfusion-dependent beta thalassemia. This recombinant fusion protein is believed to help immature cells develop into red blood cells, thereby preventing anemia and reducing or eliminating the need for frequent blood transfusions.
Ayvakit (Avapritinib) for Gastrointestinal Stromal Tumor
Ayvakit (avapritinib) is an oral potent and selective inhibitor of activated KIT and PDGFRA mutant kinases, particularly activation loop mutations and highly resistant PDGFRA D842V mutation. It is indicated for the treatment of adults with unresectable or metastatic gastrointestinal s…
Vazegepant for Acute Treatment of Migraine
Vazegepant is an intranasal novel small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist (“gepant”) drug proposed for the acute treatment of migraine headache. CGRP is involved in vasodilation and sensory transmission and is a validated target for the treatment of migraine headache.