Recently, the Janssen Pharmaceutical Companies of Johnson & Johnson reported that they submitted a New Drug Application (NDA) for intravenously administered UPTRAVI (selexipag). The therapy is designed to treat patients with pulmonary arterial hypertension (PAH) who are unable to use orally administered therapies.
UPTRAVI was originally approved as an oral treatment in 2015. It works to reduce hospitalizations in patients with PAH, as well as delay PAH progression. The Janssen Pharmaceutical Companies of Johnson & Johnson used data from a Phase 3 UPTRAVI IV study to support the NDA.
Within the study, researchers sought to understand whether patients could switch between orally administered and intravenously administer UPTRAVI. Additionally, the study looked to understand the safety, efficacy, and tolerability of the therapy. During the first treatment period, 20 patients received orally administered UPTRAVI in the morning and at night. During the second treatment period, patients received three UPTRAVI infusions. Finally, in the third treatment period, patients returned to oral doses. The recommended dose is 200mg daily.
UPTRAVI was found to be safe and well-tolerated, even while switching between different administrations. Side effects included headache, nausea and vomiting, diarrhea, jaw pain, joint and muscle pain, anemia, flushing, rash, and a low appetite.
Pulmonary Arterial Hypertension (PAH)
A chronic and progressive type of high blood pressure, pulmonary arterial hypertension (PAH) causes the thickening or hardening of pulmonary arteries. The condition often results from BMPR2 gene mutations. However, HIV, liver and lung diseases, autoimmune conditions, and drug use are also associated with PAH. Normally, pulmonary artery pressure is 14 mm Hg. Patients with PAH usually experience 25 mm Hg.
When the pulmonary arteries thicken and harden, the heart must work harder to push blood through or receive oxygen back. As a result, the heart also weakens.
PAH usually affects women between ages 30 and 60. Symptoms include fatigue, chest pain, difficulty breathing, dizziness, confusion, and inflammation in the lower extremities. Learn more about PAH here.