Renovion, Inc. Receives Orphan Designation for Arina-1 for the Treatment of Lung Dysfunction followi
Renovion, Inc. announced today that the FDA Office of Orphan Products has granted Orphan Designation in the US to the Company's nebulized therapy Arina-1 for the treatment of lung dysfunction following lung transplant.
DURHAM, NC – 1/6/2017 – Renovion, Inc. ("Renovion"), an early stage drug development company targeting the treatment of lung transplant and other chronic inflammatory respiratory diseases, announced today that the FDA Office of Orphan Products has granted Orphan Designation in the US to the Company's nebulized therapy Arina-1 for the treatment of lung dysfunction following lung transplant.
Orphan designation by the FDA is designed to incentivize the evaluation and development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. Orphan Designation is granted based on scientific and clinical data that supports the safe and effective, diagnosis or prevention of a rare disease that affects less than 200,000 persons. This designation allows for tax credits on research, FDA fee exemptions and seven years of marketing exclusivity after marketing approval is granted.
"Receiving Orphan Designation for Arina-1 is an important milestone that supports our commitment to developing this therapy for the underserved population of lung transplant patients” stated Dan Copeland, Chief Executive Officer of Renovion.
Arina-1 is currently being evaluated in a Phase 1 clinical trial in patients who have lung dysfunction following bilateral lung transplant at Duke University. The company has raised over $1 million to support the development of Arina-1 for lung transplant patients.
Over 2,000 end-stage respiratory disease patients receive a lung transplant annually. Lung transplant has one of the highest mortality rates of the solid organ transplants. The five-year mortality rate of patients with a lung transplant is 45%; the ten-year mortality rate is 80%. Currently, there are no FDA-approved therapies for patients with a lung transplant – all therapies are used for lung transplant are used off-label with variable and modest success. Renovion aims to develop Arina-1 as the first FDA-approved therapy for patients with lung transplant.
Renovion is currently raising funds to complete pre-clinical and clinical development. For more information on Arina-1 and Renovion, please visit renovion.com.
Dan Copeland, CEO
SOURCE: Renovion, Inc.