Business
Update on submission to the FDA
Update on submission to the FDA.
About this update from Immupharma Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 7510E\n Immupharma PLC\n 10 November 2020\n \n \n \n \n \n \n \n \n \n \n \n \n \n 10 November 2020\n \n \n ImmuPharma PLC\n \n \n (\"ImmuPharma\" or the \"Company\")\n \n \n \n \n \n \n Update on submission to the FDA for the\n \n \n forthcoming international Phase 3 trial of Lupuzor™ in Lupus patients\n \n \n \n \n \n \n ImmuPharma PLC (LSE:IMM) (Euronext Growth Brussels: ALIMM), the specialist drug discovery and development company, announces further regulatory and operational progress for the new optimised international Phase 3 trial of Lupuzor™ in systemic lupus erythematosus (\"SLE\") a potentially life-threatening auto-immune disease. \n \n \n \n \n \n Key highlights:\n \n \n · \n The FDA has offered to accept submission for a Type 'A' Meeting Request;\n \n \n · \n Guidance to be sought by Avion on the new Phase 3 clinical trial;\n \n \n · \n FDA also asked to consider a conditional approval of Lupuzor™, whilst Phase 3 trial underway; and\n \n \n · \n Production of new Lupuzor™ Phase 3 clinical trial material has been initiated.\n \n \n \n \n \n Following the notification by ImmuPharma, on 27 July 2020, that Avion Pharmaceuticals (\"Avion\"), ImmuPharma's licensing partner for Lupuzor™ had submitted a Special Protocol Assessment (\"SPA\") request to the US Food & Drug Administration (\"FDA\") for the new optimised international Phase 3 study, the FDA has now responded.\n \n \n \n \n \n The FDA offered to accept submission for a Type 'A' Meeting Request, following which, Avion submitted a full dossier on 6 November 2020 through the FDA Type 'A' route which, in normal circumstances, leads to a guidance meeting within 30 days. However, FDA timeframes cannot be guaranteed. The guidance meeting will address the key aspects of the study design, clinical end points and approval process.\n \n \n \n \n \n In addition, Avion has asked the FDA to consider a conditional approval while the new Phase 3 is underway. A conditional approval, which would allow the marketing of Lupuzor™ prior to the completion of the new Phase 3, would be based on the clinically significant data previously generated in the completed Phase 2 and 3 clinical trials to date. Lupuzor™ is extremely safe and well tolerated, and so, whilst the Directors believe that a suc...