United Therapeutics Corporation Announces FDA Filing Acceptance of New Drug Application for Ralinepag to Treat Pulmonary Arterial Hypertension
Ralinepag has the potential to redefine the PAH treatment landscape as the first and only once-daily oral prostacyclin, if approved by the U.S. Food and Drug Administration (FDA)
Ralinepag combines potent receptor affinity with continuous exposure to deliver long-term, durable efficacy and disease-mitigating outcomes
United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the FDA has accepted the New Drug Application (NDA) for ralinepag to treat PAH. The FDA has set a Prescription Drug User Fee Act target action date of June 24, 2027. Ralinepag has not been approved for use in any indication by the FDAand remains investigational for PAH.
“Ralinepag has the potential to make an important difference for adults living with PAH — a complex, progressive, and life-threatening disease that can severely impact daily life and lead to right heart failure,” said Martine Rothblatt, Ph.D.,Chairperson and Chief Executive Officer of United Therapeutics. “With the NDA now accepted for review, we are one step closer to offering PAH patients a new, once-daily oral treatment. In our clinical trial, ralinepag delayed disease progression, achieved clinical improvement, and provided durability of effect over many years. We attribute these robust results to its unique chemistry and multi-pathway effects, including vasodilation and anti-proliferative and anti-inflammatory activity.”
