Janssen’s Uptravi (selexipag) Receives the US FDA’s Approval for IV Use in Adults with Pulmonary Arterial Hypertension

August 2, 2021 Auto Bot approval, FDA, Janssen, Pulmonary Arterial Hypertension, regulatory 0

Shots:

  • The approval is based on P-III UPTRAVI IV study evaluating the safety, tolerability, and PK of temporarily switching Uptravi (PO) to Uptravi (IV) in 20 patients with PAH
  • The results showed that switching b/w Uptravi (PO) to Uptravi IV was well tolerated with no unexpected safety findings. Both formulations maintain the treatment effect for short-term temporary interruptions, AEs from Uptravi IV were similar to those associated with Uptravi tablets
  • Uptravi is a selective, prostacyclin IP receptor agonist, approved for IV use for PAH, WHO Group I in the adult with WHO (FC) II–III, who are temporarily unable to take oral therapy

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