FDA Approves IV Therapy for Adults With Pulmonary Arterial Hypertension
Selexipag tablets were first approved by the FDA in 2015 to delay disease progression and reduce the risk of hospitalization for PAH.
Officials with the FDA have approved selexipag (Uptravi; Janssen) injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class II–III, who are temporarily unable to take oral therapy. Selexipag is a selective prostacyclin IP receptor agonist indicated for the treatment of PAH.
Uninterrupted treatment is considered key for individuals with PAH. According to Janssen, selexipag IV is a therapeutic option that will allow patients to avoid short-term treatment interruptions and stay on regimen.
Selexipag tablets were first approved by the FDA in 2015 to delay disease progression and reduce the risk of hospitalization for PAH. The new FDA approval for selexipag is based on the findings from a prospective, multicenter, open-label single sequence crossover phase 3 study (NCT03187678)designed to assess the safety, tolerability, and pharmacokinetics of temporarily switching between selexipag tablets and selexipag IV. The results of the study were published earlier this year in Respiratory Research and examined switching from a stable dose of selexipag tablets to a corresponding dose of selexipag IV and back to the tablets.
“Today marks an important day for patients who rely on [selexipag], as this new intravenous formulation meets a current unmet need for these patients,” said Neil Davie, PhD, global therapeutic area head, pulmonary hypertension for the Actelion Pharmaceuticals division of Janssen, in a press release.
The selexipag IV study enrolled 20 patients who received all selexipag doses (either tablets or IV). The study found that the switch between tablets and the IV doses was well tolerated with no unexpected safety findings. Adverse events (AEs) that resulted from selexipag IV were similar to those associated with selexipag tablets, with the exception of infusion site reactions reported in 2 patients, both of which were considered mild-to-moderate in intensity and neither led to study or treatment discontinuation. The prostacyclin-associated AEs included headache, diarrhea, nausea, vomiting, pain in jaw, myalgia, pain in extremity, flushing, and arthralgia.
Uptravi (selexipag) receives FDA approval for intravenous use in adult patients with pulmonary arterial hypertension (PAH) [news release]. July 30, 2021; Janssen. Accessed July 30, 2021. https://www.janssen.com/uptravir-selexipag-receives-fda-approval-intravenous-use-adult-patients-pulmonary-arterial