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UPTRAVI® Receives FDA Approval for Intravenous Use in Adult Patients with Pulmonary Arterial Hypertension

07/30/2021 | 08:30am EDT

Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved UPTRAVI® (selexipag) injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) 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 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. 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. Selexipag, a selective prostacyclin IP receptor agonist, is a compound discovered by Nippon Shinyaku and licensed to Actelion Pharmaceuticals Ltd. outside Japan. It is licensed for the oral treatment of PAH in more than 60 countries. The UPTRAVI® IV study (NCT03187678) was 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 oral UPTRAVI® and UPTRAVI® IV in 20 patients. The study examined switching from a stable dose of UPTRAVI® tablets to a corresponding dose of UPTRAVI® IV and back to UPTRAVI® tablets. The treatment and observation phase was divided into three periods. In Period 1, patients received their stable oral dose of UPTRAVI® twice daily (morning and evening of Day 1). In Period 2, patients received three infusions of corresponding UPTRAVI® IV doses (morning and evening of Day 2, and morning of Day 3). In Period 3, patients resumed their stable oral UPTRAVI® dose twice daily in the evening of Day 3 for 9 days, which was continued through the safety follow-up. Patients were hospitalized during Periods 1 and 2. PAH is a specific form of pulmonary hypertension (PH) that causes the walls of the pulmonary arteries (blood vessels leading from the right side of the heart to the lungs) to become thick and stiff, narrowing the space for blood to flow, and causing an increased blood pressure to develop within the lungs. PAH is a serious, progressive disease with a variety of etiologies and has a major impact on patients' functioning as well as their physical, psychological and social wellbeing. There is currently no cure for PAH and it is often fatal.3-5 However, the last decade has seen significant advances in the understanding of the pathophysiology of PAH, transforming the prognosis for PAH patients from symptomatic improvements in exercise tolerance 10 years ago, to delayed disease progression today.

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