Reviva Pharmaceuticals, Inc. (Reviva), a privately held, clinical stage pharmaceutical company, announced that the FDA has granted Orphan Drug Designation for its clinical stage drug candidate, RP5063, for the treatment of idiopathic pulmonary fibrosis (IPF).
“Obtaining the Orphan Drug Designation is a significant regulatory milestone as well as a notable achievement for Reviva, since it validates the significant therapeutic potential of RP5063 for the treatment of IPF,” said Laxminarayan Bhat, Ph.D., founder, president and CEO of Reviva. “IPF is a devastating disease with limited treatment options and no cure. RP5063, however, provides a novel mechanism of action that has the potential to impact multiple aspects of this disease and, combined with convenient delivery options, RP5063 affords hope to many patients suffering from this debilitating disease.”
RP5063 has shown robust efficacy in highly recognized translational animal models proven to emulate pulmonary fibrosis in humans. RP5063 significantly improved survival rate, reduced inflammatory cytokines and tissue scarring (fibrosis) in the lungs of bleomycin-induced pulmonary fibrosis animal model, indicating the potential for clinically meaningful improvement and stabilization of lung function. IPF and pulmonary arterial hypertension (PAH) are fatal lung diseases that share some common pathophysiology.
Recently, the FDA has also granted Orphan Drug Designation to RP5063 for the treatment of PAH. Thus, Reviva is planning to initiate phase 2 clinical trials for IPF and PAH in the very near future.
The FDA’s Orphan Drug Designation is granted for investigational drugs that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. With the 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 from when market approval is granted.
(Source: Reviva Pharmaceuticals, Inc.)
Filed Under: Drug Discovery