Kelly Chin, MD discusses the recent FDA approval of selexipag IV and breakthroughs in the cardiovascular care space.
Last week, the US Food and Drug Administration (FDA) approved a New Drug Application (NDA) for selexipag (UPTRAVI®) intravenous (IV) injection for adult patients with pulmonary arterial hypertension (PAH) who are temporarily unable to take oral therapy.
In an interview with HCPLive, Kelly Chin, MD, study senior author and Associate Professor of Internal Medicine and Director of the Pulmonary Hypertension Program at The University of Texas Southwestern Medical Center, discussed the FDA approval and the overall utility of selexipag IV injection in treatment of PAH.
HCPLive: What is the immediate benefit and utility of the drug in PAH treatment?
Dr. Chin: For patients with pulmonary arterial hypertension (PAH), uninterrupted treatment is considered key for continuity of care. The availability of selexipag in both an oral tablet and intravenous (IV) formulation represents a solution for a previously unmet need for PAH patients on selexipag who are temporarily unable to take oral therapy. With this new formulation, selexipag patients will now be able to continue on treatment even if they are temporarily unable to take oral medication.
HCPLive: Can you describe the current state of PAH care?
Dr. Chin: PAH is a serious progressive disease with no known cure. Over the past years, therapeutic advancements have been made that have been shown to reduce disease progression and to reduce hospitalizations. The hope for the future is to one day be able to transform PAH into a manageable condition and ultimately cured.
Because PAH is a progressive and often fatal disease, it’s important to decrease the time to diagnosis and treatment initiation for individuals with PAH. Regular risk assessment for PAH patients is also essential to help physicians evaluate disease progression and could inform treatment decisions based on an individual patient’s prognosis.
HCPLive: Furthermore, how does selexipag contribute to the PAH care space?
Dr. Chin: Selexipag is an oral selective prostacyclin IP receptor agonist first approved by the FDA in 2015 for the treatment of patients with PAH (WHO Group I, FC II-III) to delay disease progression and reduce the risk of hospitalization for PAH. The availability of selexipag IV allows continuation of PAH therapy for patients who may be unable to take oral selxipag therapy.
HCPLive: How does the bridging of oral and IV therapies ultimately benefit the patient and how they manage their PAH?
Dr. Chin: Given the progressive nature of this disease, maintaining treatment is central to help manage PAH. For patients on selexipag, bridging short-term temporary interruptions of selexipag tablets with selexipag IV may maintain the treatment effect and avoid the need to change therapy or re-titrate selexipag tablets after re-initiation.
HCPLive: What are you hopeful is the next breakthrough in the PAH or cardiovascular care space?
Dr. Chin: PAH therapies have come a long way in the last several decades, but we still have a long way to go. I’m hopeful that the coming years will identify novel compounds that will lead to additional clinical benefits—lower pulmonary arterial pressures, improved quality of life and better long-term survival. In addition, we need to better utilize existing therapies; this requires additional studies to ensure that we are using the right combinations of therapy at the right time and in the right patients.
HCPLive: Is there anything else you think is important to add about this approval?
Dr. Chin: The FDA approval of selexipag IV will give physicians an option to avoid treatment interruptions and deliver continuity of therapy for their PAH patients when they’re unable to take oral medication. This is important because staying on therapy is key for patients with PAH, given the progressive nature of the disease.