Janssen Submits NDA to FDA for Intravenous UPTRAVI (selexipag) to Maintain Uninterrupted Therapy in PAH Patients Unable to Take Oral Medication

September 30, 2020 /BioValleyBIOON/ -- Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), recently announced that it has submitted to the U.S. Food and Drug Administration (FDA) submitted a New Drug Application (NDA) for the intravenous (IV) formulation of Uptravi (selexipag), indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH, WHO Group I) in WHO Functional Class II-III who are currently prescribed oral therapy but are temporarily unable to receive it. In patients with PAH, treatment interruption should be avoided due to the progressive nature of the disease.

Uptravi is a selective prostacyclin IP receptor agonist. In 2015,FDAApproved for oral Uptravi to treat PAH, delaying disease progression and reducing the risk of hospitalization.

Chemical Structure of Selexipag (Image source: Uptravi prescribing information)

This NDA is based on the results of a prospective, multicenter Phase 3 study. The study aimed to evaluate the safety and tolerability of switching patients with pulmonary arterial hypertension (PAH) from oral Uptravi to intravenous (IV) Uptravi, and then back to the initial oral dose.

The results indicate that Uptravi IV is suitable for maintaining short-term continuous infusion therapy when oral Uptravi is not feasible. The transition between oral Uptravi and Uptravi IV was well tolerated, with no unexpected safety findings. The adverse reactions associated with Uptravi IV were similar to those of Uptravi tablets, except for infusion site reactions. Prostacyclin-relatedAdverse ReactionsIncluding headache, diarrhea, nausea, vomiting, jaw pain, myalgia, extremity pain, flushing, and arthralgia.

Dr. Neil Davie, Global Therapeutic Area Head for Pulmonary Arterial Hypertension at Janssen Research & Development, stated, “Even relatively short-term interruptions in PAH treatment due to the temporary inability to take oral medications can have a significant negative impact on patients’ health. We have demonstrated that continuous treatment with Uptravi can significantly improve long-term patient outcomes. Using an intravenous formulation to prevent treatment interruptions is an important therapeutic option, and we are pleased to be one step closer to bringing this critical treatment to the PAH community.”(Bioon.com)

Original Source: Janssen Submits New Drug Applicationapplication (NDA) to U.S. FDA for UPTRAVI? (selexipag) Injection for Intravenous Use to Treat Pulmonary Arterial Hypertension (PAH)