The new IV formulation is said to allow for uninterrupted treatment for PAH patients who are temporarily unable to take oral therapy
Janssen Pharmaceutical Companies of Johnson & Johnson. (Credit: Vysotsky/Wikipedia.)
Janssen, the pharmaceutical company of Johnson & Johnson (J&J), has received the US Food and Drug Administration (FDA) approval for Uptravi (selexipag) to treat a type of pulmonary arterial hypertension (PAH).
The US agency indicated Uptravi, administered as intravenous (IV) injection for PAH in adults with WHO functional class (FC) II–III, who are temporarily ineligible for oral therapy.
The tablet formulation of the drug was previously approved in the US, in 2015, to delay disease progression and reduce the risk of hospitalisation for PAH.
Uptravi is a selective prostacyclin IP receptor agonist, originally discovered by Nippon Shinyaku and licensed to Actelion Pharmaceuticals outside Japan.
Janssen said that the IV treatment allows patients to avoid short-term treatment interruptions, as uninterrupted treatment is considered key for individuals with PAH.
Janssen pulmonary hypertension global therapeutic area head Neil Davie 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.”
The US FDA approved the New Drug Application (NDA) for Uptravi based on results from a Phase 3, multi-centre, open-label single sequence cross-over study.
The Phase 3 study is designed to evaluate the safety, tolerability and pharmacokinetics of temporarily switching between Uptravi tablets and Uptravi IV, in 20 patients.
According to the study results, the switch between tablets and IV formulation of the treatment was well tolerated with no unexpected safety findings.
The study demonstrated similar adverse events (AEs) from Uptravi IV, compared to those observed with Uptravi tablets, except for infusion site reactions.
The prostacyclin-related AEs include headache, diarrhoea, nausea, vomiting, pain in the jaw, myalgia, pain in extremity, flushing, and arthralgia.
Uptravi IV study senior author Kelly Chin 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.”