FDA Approves Selexipag IV for Pulmonary Arterial Hypertension

The US Food and Drug Administration (FDA) approved a New Drug Application (NDA) for intravenous (IV) selexipag (UPTRAVI) injection for adult pulmonary arterial hypertension (PAH) patients with WHO functional class 2-3 who are temporarily unable to take oral therapy.

The treatment, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, will enable patients to avoid short-term treatment interruptions and stay on selexipag therapy uninterrupted.

The Study

The approval is based on the results of a prospective, multi-center, open-label single sequence cross-over phase 3 study aimed at assessing the safety, tolerability, and pharmacokinetics of temporary switching between the tablet and IV formulation of the selective prostacyclin IP receptor agonist.

In the 20 patient study, researchers found the switch between tablets and IV formulations was well tolerated with no unexpected safety findings. The adverse events found from selexipag IV was similar to what has been found in previous studies with tablets, with the exception of mild-to-moderate infusion site reactions in 2 patients that did not lead to treatment discontinuation.

Some of the treatment-related adverse events included headache, diarrhea, nausea, vomiting, pain in jaw, myalgia, pain in extremities, flushing, and arthralgia.

The Drug

The treatment was first approved in tablet form in 2015 to delay disease progression and reduce the risk of hospitalization for PAH.

"Given the progressive nature of this disease, maintaining treatment is important to help control PAH,” said Kelly Chin, MD, study senior author and Associate Professor of Internal Medicine and Director of the Pulmonary Hypertension Program at The University of Texas Southwestern Medical Center, in a statement. “However, there are times where patients may be unable to take oral medications. For patients on UPTRAVI, bridging short-term temporary interruptions of UPTRAVI tablets with UPTRAVI IV may maintain the treatment effect and avoid the need to change therapy or re-titrate UPTRAVI tablets after re-initiation."