FDA Approves IV Formulation of Uptravi for Pulmonary Arterial Hypertension

The FDA approval of the New Drug Application (NDA) for UPTRAVI is based upon the findings from a prospective, multi-center, open-label single sequence cross-over Phase 3 study designed to assess the safety, tolerability, and pharmacokinetics of temporarily switching between UPTRAVI tablets and UPTRAVI IV. The results of the study were published earlier this year in Respiratory Research and examined switching from a stable dose of UPTRAVI tablets to a corresponding dose of UPTRAVI IV and back to UPTRAVI tablets.2

"Today marks an important day for patients who rely on UPTRAVI, as this new intravenous formulation meets a current unmet need for these patients. As part of our commitment to investing in research and understanding the science around the potential of UPTRAVI, we're inspired by this approval and are proud to be paving the way to advance treatment options and care for patients with PAH," said Neil Davie, PhD, Global Therapeutic Area Head, Pulmonary Hypertension, Janssen.

The UPTRAVI IV study enrolled 20 patients who received all UPTRAVI doses (either tablets or IV). The study found that the switch between UPTRAVI tablets and UPTRAVI IV was well tolerated with no unexpected safety findings. Adverse events (AEs) that resulted from UPTRAVI® IV were similar to those associated with UPTRAVI tablets, with the exception of infusion site reactions reported in two patients (both of which were considered mild-to-moderate in intensity and neither led to study and/or treatment discontinuation). The prostacyclin-associated AEs included headache, diarrhea, nausea, vomiting, pain in jaw, myalgia, pain in extremity, flushing, and arthralgia.