A recent article in “Pulmonary Hypertension News” reports on the tentative approval of Alembic Pharmaceuticals’ generic selexipag as pulmonary arterial hypertension treatment for pulmonary arterial hypertension. Alembic’s generic selexipag contains the same chemical substance as an approved treatment, Uptravi for injection, sold by Johnson & Johnson.
Selexipag is a prostacyclin receptor agonist that leads to vasodilation in the pulmonary circulation. It was first approved as an oral treatment with the name of Uptravi by the US Food and Drug Administration (FDA) in 2015, and in Europe and Canada the following year.
In 2021, the therapy received FDA approval for an intravenous (IV), or into-the-vein, formulation. The target popoulation was patients already treated with selexipag administered orally who were hospitalized or unable to swallow tablets in order to avoid treatment interruptions. A Phase 3 trial (NCT03187678) switching from oral to intravenous Uptravi, was found to be safe and well tolerated. Patients reported mild side effects similar to those of the oral treatment.
Read more at this link on Pulmonary Hypertension News
