Reviva Pharmaceuticals has announced the granting of Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its lead development product, RP5063, for the treatment of pulmonary arterial hypertension (PAH).
"We are pleased to receive Orphan Drug Designation for RP5063, which emphasizes the significant need for new mediations for patients suffering from PAH,” said Laxminarayan Bhat, PhD, Reviva's Founder, President and Chief Executive Officer. "In conjunction with our other clinical-stage programs, this compound further enhances Reviva's value drivers.”
“Based on the mechanism of action, demonstrated preclinical efficacy, and convenient delivery options for enhanced compliance, we believe that RP5063 could become a ‘first in class’ therapy for PAH,” said Marc Cantillon, MD, Reviva’s Chief Medical Officer. “Having already completed clinical studies phase 1, and phase 2 in patients with schizophrenia and schizoaffective disorders, we look forward to rapidly advancing this drug candidate into a phase 2 study in PAH patients. Many PAH patients also suffer from comorbid depression and psychosis which current medications do not address.”
The FDA’s Orphan Drug Designation program provides orphan status to drugs and biologics that are being developed to address rare diseases or disorders that affect fewer than 200,000 people in the U.S. With orphan designation, Reviva qualifies for various incentives including FDA assistance in clinical trial design, tax credits for clinical trial costs, an exemption from the FDA user fee, and seven years of market exclusivity in the United States, if market approval is granted for RP5063.