FDA Approves Uptravi (selexipag) for Intravenous Use in Adult Patients with PAH

The US 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.

Uptravi is a therapeutic option that will allow patients to avoid short-term treatment interruptions and remain on Uptravi therapy, as continuous treatment is considered important 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.

Kelly Chin, Associate Professor of Internal Medicine and Director of the Pulmonary Hypertension Program at The University of Texas Southwestern Medical Center, said, “Given the progressive nature of this disease, maintaining treatment is important to help control PAH. 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”.

The FDA‘s approval of the New Drug Application (NDA) for Uptravi is based on the findings of a prospective, multi-center, open-label single sequence cross-over phase 3 study on the safety, tolerability, and pharmacokinetics of a temporary switch. is designed to assess. Uptravi Tablets and Uptravi IV. The study results were published earlier this year in Respiratory Research and examined switching from a stable dose of Uptravi tablets to a similar dose of Uptravi IV and back to Uptravi tablets.

Neil Davie, PhD., Global Therapeutic Area Head, Pulmonary Hypertension, Janssen, said, “Today marks an important day for patients who rely on Uptravi, as this new intravenous formulation meets a current unmet need for these patients. As part of our commitment to investing in research and understanding the science around the potential of Uptravi, we’re inspired by this approval and are proud to be paving the way to advance treatment options and care for patients with PAH”.