CANTEX PHARMACEUTICALS RECEIVES FDA ORPHAN DRUG DESIGNATION FOR AZELIRAGON FOR THE TREATMENT OF GLIOBLASTOMA
WESTON, Fla., Jan. 9, 2023 /PRNewswire/ -- Cantex Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions for which new treatments are urgently needed, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Cantex' azeliragon, a well-tolerated once-a-day pill, for the treatment of glioblastoma.
- WESTON, Fla., Jan. 9, 2023 /PRNewswire/ -- Cantex Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions for which new treatments are urgently needed, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Cantex' azeliragon, a well-tolerated once-a-day pill, for the treatment of glioblastoma.
- By preventing interaction of RAGE with these ligands, azeliragon may inhibit glioblastoma and overcome its resistance to effective treatment.
- "Receiving FDA orphan drug status for azeliragon highlights the significant unmet need for novel treatment options for patients with glioblastoma, the most common and lethal primary brain cancer," commented Stephen G. Marcus, M.D., Chief Executive Officer of Cantex.
- FDA Orphan Drug Designation provides Cantex with seven years of azeliragon marketing exclusivity from the time of product launch for the orphan indication, and several other important benefits, including assistance in the drug development process, tax credits for clinical costs, and exemptions from certain FDA fees.