Orphan Status Granted to Investigational Pulmonary Arterial Hypertension Drug

Selten Pharma announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to tacrolimus (SPI-026) for the treatment of pulmonary arterial hypertension.

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Selten's SPI-026 program is evaluating SPI-026, an investigational bone morphogenetic protein receptor type II (BMPR2) pathway activator for the treatment of patients with pulmonary arterial hypertension. In studies, SPI-026 prevented the development of PAH in mice with a deletion of BMPR2 endothelial cells in a chronic hypoxia model, and reversed PAH and neointimal/occlusion in the lungs in rats with neointima formation following VEGF receptor blockade and chronic hypoxia. It has been shown to be safe and tolerable in patients with PAH.

For more information visit SeltenPharma.com.