JNJ’s UPTRAVI (selexipag) Receives FDA Approval for Intravenous Use in Adults

The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced that the FDA approved UPTRAVI® (selexipag) injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients with WHO functional class (FC) II–III, who are temporarily unable to take oral therapy.

UPTRAVI® (selexipag) is a prescription medicine used to treat pulmonary arterial hypertension (PAH, WHO Group 1), which is high blood pressure in the arteries of your lungs.

UPTRAVI® IV is a therapeutic option that will allow patients to avoid short-term treatment interruptions and stay on UPTRAVI® therapy, as uninterrupted treatment is considered key for individuals with PAH.

Pulmonary arterial hypertension (PAH) is a rare, progressive disorder characterized by high blood pressure (hypertension) in the arteries of the lungs (pulmonary artery) for no apparent reason. The pulmonary arteries are the blood vessels that carry blood from the right side of the heart through the lungs.

Symptoms of PAH include shortness of breath (dyspnea) especially during exercise, chest pain, and fainting episodes. The exact cause of PAH is unknown and although treatable, there is no known cure for the disease. PAH usually affects women between the ages of 30-60.

Recently, JNJ created a website with online patient network The Mighty that features hand-drawn videos with patient and physician voice-overs telling their stories about the rare progressive blood pressure disorder.

UPTRAVI’s 2020 worldwide revenues increased to $1.1 billion from $819 million in 2019. Sales in the U.S. increased to $955 million in 2020 from $714 million in 2019. The following specialty pharmacies can provide UPTRAVI to patients: Accredo and CVS Specialty.

 

Takeaway: New cases of PAH are estimated to occur in one to two individuals per million each year in the U.S. The incidence is estimated to be similar in Europe. Approximately 500-1000 new cases of PAH are diagnosed each year in the U.S.