(Alliance News) - ImmuPharma PLC on Friday said its licencing partner for Lupuzor, Avion Pharmaceuticals LLC, has a set date for talks with the US Food & Drug Administration concerning the drug.
The London-based pharmaceutical development company said Avion will be meeting with the FDA on December 4 to discuss the phase three trial of Lupuzor, a potential treatment for auto-immune disease Lupus.
In the discussions, Avion will be asking the FDA for guidance on key aspects of the study design, clinical end points and approval process for Lupuzor as well as consideration by the FDA for the conditional approval of Lupuzor while the phase three trial is underway.
ImmuPharma Chief Executive Dimitri Dimitriou said: "ImmuPharma and Avion are delighted that the FDA are expediting the Type 'A' meeting for early December. We look forward to providing a further update to the market following confirmation from Avion of the FDA's guidance post this meeting."
ImmuPharma shares were up 18% at 12.95 pence each in London on Friday.
By Greg Roxburgh; gregroxburgh@alliancenews.com
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