U.S. Food and Drug Administration Grants Orphan Drug Designation to Solaxa Inc.
Bethesda, MD; July 26, 2024 – Solaxa Inc. announces that the U.S. Food and Drug Administration has granted the company orphan drug designation for the use of 4-aminopyradine (4–AP), for the treatment of spinocerebellar ataxia (SCA), a group of progressive, neurodegenerative inherited (autosomal dominant) diseases that adversely affect cerebellar function, resulting in loss of muscle control, coordination, and balance. A key benefit of this designation is 7-years of market exclusivity upon approval of the drug for use in SCA.
The company’s Founder and Chief Executive Officer, Christian Walker, noted that “Solaxa is committed to developing new treatments for rare forms of ataxia and we were pleased to see our research featured at this year’s National Ataxia Foundation’s Annual Ataxia Conference.” Moreover, “we appreciate both this orphan drug designation and the encouraging feedback which FDA has provided to us as we prepare our investigational new drug (IND) application to begin human clinical studies in patients with SCA.”
About Solaxa
Solaxa is a clinical-stage biopharmaceutical public benefit corporation developing treatments that restore nerve function in patients with rare neurodegenerative diseases and acute nerve injuries. The company is developing a class of aminopyridine drugs that both detect and treat ion channel dysfunction. Solaxa’s public benefit mission is to advance scientific knowledge and deliver impactful and accessible therapies that improve outcomes for patients worldwide.
For more information, visit Solaxa.com.
CONTACT:
Luis Gutierrez, COO
Solaxa Inc.