Beovu is a human vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD). Inhibition of the VEGF pathway is believed to impede the growth of neovascular lesions, resolve retinal edema, and improve vision in patients with neovascular AMD.
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.
Scenesse (Afamelanotide) for Erythropoietic Protoporphyria
Scenesse is a subcutaneous implant containing a synthetic analog of alpha-melanocyte stimulating hormone. It is indicated to increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria.
Scenesse (Afamelanotide) for Erythropoietic Protoporphyria
Scenesse is a subcutaneous implant containing a synthetic analog of alpha-melanocyte stimulating hormone. It is indicated to increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria.
Endari (Pharmaceutical Grade L-Glutamine)
Endari (oral pharmaceutical grade L-glutamine) is an amino acid with antioxidant properties indicated to reduce the acute complications of sickle cell disease (SCD) in adult and pediatric patients 5 years of age and older. It is a precursor for nicotinamide adenine dinucleotide (NAD), which is deficient in patients with SCD. A definitive mechanism of action is not yet defined…
Endari (Pharmaceutical Grade L-Glutamine)
Endari (oral pharmaceutical grade L-glutamine) is an amino acid with antioxidant properties indicated to reduce the acute complications of sickle cell disease (SCD) in adult and pediatric patients 5 years of age and older. It is a precursor for nicotinamide adenine dinucleotide (NAD), which is deficient in patients with SCD. A definitive mechanism of action is not yet defined…
Ofev (Nintedanib) for Systemic Sclerosis-Associated Interstitial Lung Disease
Ofev (nintedanib) is a small molecule that inhibits multiple receptor tyrosine kinases that play an important role in the pathogenesis of fibrosis. The inhibition of these receptors is believed to decrease collagen and fibronectin formation, thereby slowing the rate of decline in pulmonary function in patients with systemic sclerosis.
Ofev (Nintedanib) for Systemic Sclerosis-Associated Interstitial Lung Disease
Ofev (nintedanib) is a small molecule that inhibits multiple receptor tyrosine kinases that play an important role in the pathogenesis of fibrosis. The inhibition of these receptors is believed to decrease collagen and fibronectin formation, thereby slowing the rate of decline in pulmonary function in patients with systemic sclerosis.
Xpovio (Selinexor) for Relapsed/Refractory Multiple Myeloma
Xpovio is a first-in-class oral selective inhibitor of the nuclear export protein exportin-1 (XPO1). Xpovio is believed to bind with and inhibit XPO1, causing tumor suppressor proteins to accumulate in the cell nucleus and inducing apoptosis in cancer cells while preserving normal cells. It is indicated to treat patients with heavily pretreated relapsed/refractory multiple my…
Xpovio (Selinexor) for Relapsed/Refractory Multiple Myeloma
Xpovio is a first-in-class oral selective inhibitor of the nuclear export protein exportin-1 (XPO1). Xpovio is believed to bind with and inhibit XPO1, causing tumor suppressor proteins to accumulate in the cell nucleus and inducing apoptosis in cancer cells while preserving normal cells. It is indicated to treat patients with heavily pretreated relapsed/refractory multiple my…
Barostim Neo System for Heart Failure
The Barostim neo System is an implantable neuromodulation device designed to improve cardiac function by delivering electrical stimulation to baroreceptors in the wall of the carotid artery. The system is designed to take advantage of the body’s natural baroreflex system. Activation of baroreceptors in the wall of the carotid artery with baroreflex activation therapy stimulat…