FDA Approves IV Therapy for Adults With Pulmonary Arterial Hypertension – Pharmacy Times

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 IIIII, 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, selexipagIV is a therapeutic option that will allow patients to avoid short-term treatment interruptions and stay on regimen.

Selexipagtablets 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 selexipagtablets and selexipagIV. The results of the study were published earlier this year inRespiratory Researchand examined switching from a stable dose of selexipagtablets to a corresponding dose of selexipagIV and back to thetablets.

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 selexipagIV study enrolled 20 patients who received all selexipagdoses (either tablets or IV). The study found that the switch between tablets and theIV doses was well tolerated with no unexpected safety findings. Adverse events (AEs) that resulted from selexipagIV were similar to those associated with selexipagtablets, 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.

REFERENCE

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

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FDA Approves IV Therapy for Adults With Pulmonary Arterial Hypertension - Pharmacy Times