FT011, Certa Therapeutics’ oral treatment candidate for systemic sclerosis (SSc), will now be known under the generic name asengeprast. That decision was made by the World Health Organization (WHO), which is responsible for assigning International Non-Proprietary Names, or INNs, to pharmaceutical substances or active ingredients. INNs are globally…
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Some types of disease-specific antibodies are more common in Black patients with scleroderma than white patients, a study shows. Differences in antibody profiles may help explain why clinical outcomes tend to differ for patients of different races, but the data suggest these variations can’t fully account for all the…
The U.S. Food and Drug Administration (FDA) has granted orphan drug status to Aisa Pharma’s Profervia (cilnidipine), an investigational oral calcium channel blocker also known as AISA-021, for the treatment of systemic sclerosis (SSc). In its request package for the designation, the company included data from an ongoing…
Higher circulating levels of a protein called thymic stromal lymphopoietin, or TSLP, may be linked to a greater risk of digital ulcers — sores in the fingers and toes — in people with systemic sclerosis (SSc), also known as scleroderma, a study revealed. These findings suggest that assessments of…
Long-term treatment with Volibris (ambrisentan), marketed as Letairis in the U.S., may help prevent mild pulmonary vascular disease from developing into pulmonary arterial hypertension (PAH) in people with scleroderma, a study suggested. “Early treatment and close follow-up could be beneficial in this high-risk group,” wrote the researchers…
Intravenous immunoglobulin (IVIG) eases skin, muscle and digestive symptoms in people with scleroderma (SSc), particularly when used as an add-on therapy, according to a recent review study. While no improvements were seen in respiratory function, IVIG still led to stabilization of these symptoms. The findings “suggest that IVIG…
Scleroderma patients who have cancer may be treated with radiotherapy without a notable risk of skin and pulmonary worsening, a review study suggests, but around 25% of patients saw severe acute and late toxicities, that is, side effects months after radiation therapy. As such, “individualized assessment, close collaboration between…
Cells present along the walls of small blood vessels in the lungs, called pericytes, have distinct gene activity in people with systemic sclerosis (SSc)-associated pulmonary fibrosis (PF), according to a new study. Pericytes from SSc patients showed an increased expression, or activity, of genes involved in lung fibrosis (scarring), blood…
The European Medicines Agency (EMA) has granted orphan drug status to FT011, an oral therapy candidate that Certa Therapeutics is developing for systemic sclerosis (SSc). The U.S. Food and Drug Administration (FDA) awarded the therapy a similar status last year, followed by fast track designation this year.
Patients with systemic sclerosis (SSc) who have a stem cell transplant see normalized gene activity related to immune function up to 4.5 years after the procedure. That’s according to recent data from samples in the Phase 2/3 SCOT trial (NCT00114530), wherein the potential benefits of a stem cell…
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