Janssen Reports the NDA Submission to the US FDA for Uptravi (selexipag, IV) to Treat Pulmonary Arterial Hypertension

October 1, 2020 Auto Bot Janssen, NDA, Pulmonary Arterial Hypertension, regulatory, reports, Submission, Treat, USFDA 0

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  • The NDA submission is based on P-III UPTRAVI IV study he safety and tolerability of 20 patients with PAH temporarily switching from oral UPTRAVI to UPTRAVI IV, and then transitioning back to the initial oral dose
  • Results demonstrated that Uptravi IV is suitable to maintain continuous dosing for short periods of time when the oral formulation is not feasible. Both the formulation was well tolerated with no unexpected safety findings
  • Uptravi is a selective, prostacyclin IP receptor agonist, approved in IV formulation for PAH, WHO Group I in adults with WHO functional class (FC) II–III, who are currently prescribed oral Uptravi but are temporarily unable to take oral therapy

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