News

FDA paves way for Phase 2 study of TX45 in PH-HFpEF patients

The U.S. Food and Drug Administration has given Tectonic Therapeutic the go-ahead to start a Phase 2 clinical trial of TX45, the company’s experimental treatment for pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). “We remain enthusiastic about the potential of TX45 to address the…

ZM001 for PAH gets FDA orphan drug designation

The U.S. Food and Drug Administration (FDA) has given orphan drug designation to ZM001, a first-in-class investigational antibody from Zymedi for pulmonary arterial hypertension (PAH). ZM001 is intended to reduce inflammation and tissue fibrosis (or scarring) in people with PAH. A Phase 1 clinical trial (NCT05967299) began dosing…

Healthcare costs decline after PAH diagnosis, study says

Patients with an intermediate to high risk of mortality in the first year following a pulmonary arterial hypertension (PAH) diagnosis have poorer health-related quality of life than those at lower risk, according to a study in England. Those costs were reduced following diagnosis, mainly due to less spending…

EU committee recommends combo tablet Yuvanci be approved for PAH

A committee of the European Medicines Agency (EMA) has recommended that Yuvanci, a tablet containing macitentan and tadalafil, be approved for pulmonary arterial hypertension (PAH). The positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) specifically recommends Yuvanci be approved for PAH in individuals with…

Measuring blood vessel function in arm may help predict PH: Study

Measuring blood vessel function in the arm in a noninvasive way can help predict pulmonary hypertension (PH) when combined with certain heart measurements, a study has found. The study, “Endothelial Function Correlates With Pulmonary Pressures in Subjects With Clinically Suspected Pulmonary Hypertension,” was published in The American Journal…

Molecules in blood, urine may help detect PH in children with CHD

Two molecules, 5-hydroxyindoleacetic acid (5-HIAA) and insulin-like growth factor 1 (IGF-1), showed a potential to diagnose pulmonary hypertension  early in children with congenital heart disease based on their levels in blood and urine samples examined in a study. 5-HIAA is the main product of the breakdown of serotonin, a…

Economic burden in PAH mainly due to treatment, hospital costs

Healthcare costs were found to be more than eight times higher for people with pulmonary arterial hypertension (PAH) compared with patients without the disease in a real-world study — which contributed to the greater economic burden seen for those being treated for PAH. These costs were mainly driven by…

Sildenafil may help treat PH in newborns at high altitudes

Sildenafil — a medication that relaxes blood vessels, thereby increasing blood flow — may possibly be used to treat neonatal pulmonary hypertension in babies born at high altitudes, where less oxygen is available for breathing. This is according to clinical observations by Alexandra Heath-Freudenthal, MD, a pediatric cardiologist, while…

FDA tentatively approves generic selexipag as PAH treatment

The U.S. Food & Drug Administration (FDA) has tentatively approved Alembic Pharmaceuticals‘ generic formulation of injectable selexipag as a treatment for pulmonary arterial hypertension (PAH). As a generic drug, which contains the same chemical substance as an approved treatment, it’s equivalent to Uptravi (selexipag) for injection (1,800…

New European patent covers Reviva’s brilaroxazine in PH

Reviva Pharmaceuticals has been granted a patent in Europe that covers using brilaroxazine, formerly RP5063, for pulmonary hypertension (PH). The patent covers patients with pulmonary arterial hypertension (PAH) and those who develop PH associated with chronic obstructive pulmonary disease (COPD), an inflammatory lung disorder, or sickle…