[Source: Marketwire] – ImmuneRegen BioSciences Inc.®, a wholly owned subsidiary of IR Biosciences Holdings Inc. (OTCBB: IRBS), today announced the submission of an application for Orphan Drug Product Designation for the company’s lead compound, Homspera®, for the application of treating Idiopathic Pulmonary Fibrosis, a deadly pulmonary disease with no FDA-approved treatments.
The United States Orphan Drug Act was created in 1983 to provide incentives for companies to develop and market treatments for diseases or conditions affecting fewer than 200,000 people in the United States. The designation provides eligibility for a seven-year period of market exclusivity in the United States after product approval, a waiver of user fees, the potential for grant funding, and tax benefits for clinical trials. Many orphan products receive expedited review or accelerated approval because they are for serious or life-threatening diseases.
For more information: ImmuneRegen BioSciences Submits Homspera® for FDA Orphan Drug Product Designation for the Treatment of Idiopathic Pulmonary Fibrosis