Reviva Pharmaceuticals Inc. (Reviva) announced on April 10th that it received Orphan Drug Designation from the United States Food and Drug Administration (FDA) for one of its experimental candidates. The clinical stage drug currently undergoing tests for the treatment of idiopathic pulmonary fibrosis is known as RP5063. Keep reading to learn or visit the original source for additional details.
Idiopathic pulmonary fibrosis is a rare disease in which the lung tissues begin to harden as a result of unknown causes. Common symptoms include shortness of breath, and a persistent, dry cough. Idiopathic pulmonary fibrosis mainly affects the lungs but can also affect other parts of the body, such as the stomach, hands, and feet, as a result of lower oxygen levels absorbed by the body. Life expectancy with idiopathic pulmonary fibrosis averages three to five years. No cure currently exists for idiopathic pulmonary fibrosis.
According to Laxminarayan Bhat, Ph.D., Reviva’s Founder, President and CEO, RP5063 represents a new way forward against idiopathic pulmonary fibrosis. It’s specific and unique “mechanism of action” hits the disease on multiple fronts. Administration of RP5063 is said to be as simple as it is effective.
Dr. Bhat recognizes the Oprhan Drug Designation as a significant milestone for his company and the drug they are developing. This kind of endorsement by the FDA, Bhat says, validates the work they have been doing on RP5063 as well as the effects it appears to have against idiopathic pulmonary fibrosis.
The FDA awards Orphan Drug Designation to investigational drugs which treat rare disease affecting fewer than 200,000 patients in the US. As a result of the orphan drug status, Reviva gains FDA assistance in clinical trail design, and becomes eligible for certain tax credits. The company also gains exemption from the FDA user fee, and a seven year market exclusivity in the United States.
RP5063 proved itself earlier in a series of recognized translational animal models. These models represented pulmonary fibrosis in humans, and the drug showed a “robust efficiency.”
RP5063 improved the ability of subjects to survive, reduced inflammatory cytokines, and reduced scarring in several lung tissues. Reviva plans to begin a phase 2 clinical trial utilizing RP5063 shortly.