Posted by Michael Wonder on 30 Sep 2020
Janssen submits new drug application to U.S. FDA for Uptravi (selexipag) injection for intravenous use to treat pulmonary arterial hypertension
30 September 2020 - Janssen today announced the submission of a new drug application to the U.S. FDA for Uptravi (selexipag) as an injection for intravenous use for the treatment of pulmonary arterial hypertension (WHO Group I) in adults with WHO functional class II–III, who are currently prescribed oral Uptravi but are temporarily unable to take oral therapy.
In patients with pulmonary arterial hypertension, interruptions in treatment should be avoided due to the progressive nature of the disease.
The new drug application is based on the prospective, multi-centre Phase 3 trial 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.
