The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for UPTRAVI® (selexipag) as an injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults with WHO functional class (FC) II–III, who are currently prescribed oral UPTRAVI but are temporarily unable to take oral therapy. In patients with PAH, interruptions in treatment should be avoided due to the progressive nature of the disease.
UPTRAVI is a selective, prostacyclin IP receptor agonist. Oral UPTRAVI was approved by the FDA in 2015 for the treatment of PAH to delay disease progression and reduce the risk of hospitalization.
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"Even relatively short-term PAH treatment interruptions due to a temporary inability to take oral medication, like during surgery, can have a significant negative impact on a person's health," said Neil Davie, Ph.D., Global Therapeutic Area Head, Pulmonary Hypertension, Janssen Research & Development. "We have demonstrated that continued treatment with UPTRAVI can significantly improve patients' long-term outcomes. Preventing an interruption of treatment with an IV formulation is an important therapeutic option and we are pleased to be one step closer to bringing this important treatment to the PAH community."
The NDA is based on the prospective, multi-center Phase 3 study designed to evaluate the safety and tolerability of patients with PAH temporarily switching from oral UPTRAVI to UPTRAVI IV, and then transitioning back to the initial oral dose. Results showed that UPTRAVI IV is suitable to maintain continuous dosing for short periods of time when oral administration of UPTRAVI is not feasible.