FDA Approves Janssen's Uptravi (Selexipag) Intravenous Formulation for PAH Patients Temporarily Unable to Take Oral Therapy

Janssen Pharmaceuticals, a Johnson & Johnson (JNJ) company, recently announced that the U.S. Food and Drug Administration (FDA) has approved Uptravi (selexipag) intravenous (IV) formulation for the treatment of adult patients with pulmonary arterial hypertension (PAH, WHO Group 1) WHO functional class II–III who are currently prescribed oral therapy but are temporarily unable to receive oral medication. In patients with PAH, treatment interruption should be avoided due to the progressive nature of the disease. This newly approved formulation allows PAH patients who are temporarily unable to receive oral therapy to maintain uninterrupted treatment.

Uptravi is a selective prostacyclin IP receptor agonist. Uptravi tablets were first approved by the U.S. FDA in 2015 for the treatment of PAH to delay disease progression and reduce the risk of hospitalization due to PAH. Uptravi IV is a treatment option that allows patients to avoid short-term treatment interruptions, enabling them to continue Uptravi therapy.

Ensuring uninterrupted treatment is critical for patients with PAH. Because even a relatively short-term interruption of PAH therapy due to a temporary inability to take oral medications can have a significant negative impact on patient health, studies have confirmed that continuous Uptravi therapy can significantly improve patients' long-term prognosis. Using Uptravi IV to prevent interruptions in Uptravi treatment represents an important therapeutic option for PAH patients.

This approval is based on the results of a prospective, multicenter, open-label, single-sequence crossover Phase 3 study (NCT03187678). The study enrolled 20 patients and was designed to evaluate the safety and tolerability of switching patients with PAH from a stable dose of Uptravi tablets to the corresponding dose of Uptravi IV, and then switching back to their initial Uptravi tablet dose. The results demonstrated that Uptravi IV is suitable for maintaining short-term continuous infusion therapy when oral Uptravi tablets are not feasible. The switch between Uptravi tablets and Uptravi IV was well tolerated, with no unexpected safety findings. The adverse reactions of Uptravi IV were similar to those of Uptravi tablets, with the exception of infusion site reactions. Prostacyclin-related adverse reactions included headache, diarrhea, nausea, vomiting, jaw pain, myalgia, pain in extremities, flushing, and arthralgia.

The results of this study were published earlier this year in the international medical journal *Respiratory Research*, see: Temporarily switching from oral to intravenous selexipag in patients with pulmonary arterial hypertension: safety, tolerability, and pharmacokinetic results from an open-label, phase III study.

Chemical Structure of Selexipag (Image Source: Uptravi Tablet Prescribing Information)

Uptravi IV: Kelly Chin, senior author of the aforementioned study, Director of the Pulmonary Hypertension Program, and Associate Professor of Internal Medicine at UT Southwestern Medical Center, stated: “Given the progressive nature of this disease, maintenance therapy is crucial for managing PAH. However, patients may occasionally be unable to take oral medications. For patients on Uptravi, using Uptravi IV to bridge a short-term temporary interruption of Uptravi tablets can maintain therapeutic efficacy, thereby avoiding the need to change therapy or re-titrate oral Uptravi upon reinitiation of treatment.”

Dr. Neil Davie, Global Therapeutic Area Head for Pulmonary Arterial Hypertension at Janssen Research & Development, stated: "Today is a significant day for patients who rely on Uptravi, as this new intravenous formulation addresses an unmet need for these patients. As part of our commitment to investing in research and understanding the science behind Uptravi's potential, we are inspired by this approval and proud to help pave the way for advancing treatment options and care for patients with PAH."

Original Source: UPTRAVI® (selexipag) Receives FDA Approval for Intravenous Use in Adult Patients with Pulmonary Arterial Hypertension (PAH)

This article is sourced from Bioon. For more information, please download the Bioon APP (http://www.bioon.com/m/)