FDA approves selexipag for IV use in adults with PAH
The FDA has approved selexipag for IV use in adults with WHO functional class II to III pulmonary arterial hypertension who are temporarily unable to take oral therapy.
Selexipag (Uptravi, Janssen) for IV use will allow patients to avoid short-term interruptions and stay on their therapy, as uninterrupted treatment is important for patients with PAH, according to a company press release.
Selexipag tablets were previously approved by the FDA in 2015 to delay PAH progression and reduce risk for hospitalization.
“Today marks an important day for patients who rely on Uptravi, as this new intravenous formulation meets a current unmet need for these patients,” Neil Davie, PhD, Global Therapeutics Area Head, pulmonary hypertension, Janssen Pharmaceuticals, said in the release.
This FDA approval was based on results from a prospective, multicenter, open-label, single-sequence crossover, phase 3 study that assessed the safety, tolerability and pharmacokinetics of switching from selexipag tablets to IV selexipag. In this study, switching between selexipag tablets and IV treatment was well tolerated among the 30 patients with PAH enrolled. Researchers observed no unexpected safety findings and IV selexipag adverse events were similar to those observed with the tablets.
“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,” Kelly Chin, MD, associate professor of internal medicine and director of the Pulmonary Hypertension Program at the University of Texas Southern Medical Center, said in the release. “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.”