Janssen's UPTRAVI IV FDA-Approved for PAH

The Janssen Pharmaceutical Companies of Johnson & Johnson received approval from the FDA for UPTRAVI (selexipag) injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II–III, who are temporarily unable to take oral therapy. UPTRAVI IV is a therapeutic option that will allow patients to avoid short-term treatment interruptions and stay on UPTRAVI therapy, as uninterrupted treatment is considered key for individuals with PAH. UPTRAVI® tablets were first approved by the FDA in 2015 to delay disease progression and reduce the risk of hospitalization for PAH.

The approval 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 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.