FDA confirms 4 December 2020 for Type ‘A’ meeting to discuss guidance on forthcoming international Phase 3 trial of Lupuzor™ in Lupus patients20th November 2020 - 2:48 pm
ImmuPharma PLC (LSE:IMM) (Euronext Growth Brussels: ALIMM), the specialist drug discovery and development company, announces an update on the announcement issued on 10 November 2020, in respect to the new optimised international Phase 3 trial of Lupuzor™ in systemic lupus erythematosus (“SLE”), a potentially life-threatening auto-immune disease.
The US Food & Drug Administration (“FDA”) has now confirmed the date of 4 December 2020 for a Type ‘A’ Meeting Request, with Avion Pharmaceuticals (“Avion”), ImmuPharma’s licensing partner for Lupuzor™.
As part of the Type ‘A’ Meeting, Avion has asked the FDA for guidance on the following:
- Key aspects of the study design, clinical end points and approval process for Lupuzor™; and
- Consideration by the FDA for a conditional approval of Lupuzor™, whilst the Phase 3 trial is underway.
ImmuPharma will provide an update as soon as Avion has met with the FDA and notified ImmuPharma of the outcome.
Commenting on the announcement, Dimitri Dimitriou, CEO of ImmuPharma said:
“ImmuPharma and Avion are delighted that the FDA are expediting the Type ‘A’ Meeting for early December 2020. We look forward to providing a further update to the market following confirmation from Avion of the FDA’s guidance post this meeting.”
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014. (“MAR”)
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