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.

Anifrolumab for Systemic Lupus Erythematosus

Anifrolumab is an investigational 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 proposed for the treatment of adults with moderately to severely active systemic lupus erythematosus (SLE) who are receiving standard care.

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Inclisiran for Hypercholesterolemia

Inclisiran is a subcutaneously administered, investigational RNAi therapeutic that decreases hepatic synthesis of proprotein convertase subtilisin kexin type 9 (PCSK9), leading to increased low-density lipoprotein (LDL) receptor expression on the hepatocyte cell surface and subsequently to greater removal of LDL-C from circulation.

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Oxlumo (Lumasiran) for Primary Hyperoxaluria Type 1

Oxlumo (lumasiran) is a subcutaneously injected, HAO1-directed small interfering ribonucleic acid (siRNA) indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients. Dosing is weight-based; for children weighing less than 10 kg, the recommended maintenance dose is 3 mg/kg once monthly. Dosing for individua…

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Lisocabtagene Maraleucel for Large B-Cell Lymphoma

Lisocabtagene maraleucel (liso-cel) is an investigational, 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 proposed to treat adults with relapsed or refractory large B-cell lymphoma after at least 2 prior therapies.

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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 proposed for the treatment of achondroplasia.

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