ImmuPharma gets December date for FDA meeting

20th Nov 2020 12:15

(Sharecast News) - Specialist drug discovery and development company ImmuPharma updated the market on the new optimised international phase 3 trial of 'Lupuzor' in systemic lupus erythematosus (SLE) on Friday, reporting that the US Food & Drug Administration (FDA) has now confirmed the date of 4 December for a Type 'A' Meeting Request.
The AIM-traded firm said the FDA had confirmed the date with Avion Pharmaceuticals, which is its licensing partner for Lupuzor.

As part of the Type 'A' Meeting, Avion had asked the FDA for guidance on key aspects of the study design, clinical end points and approval process for Lupuzor, and consideration for a conditional approval of Lupuzor while the phase 3 trial is underway.

ImmuPharma said it would provide an update as soon as Avion had met with the FDA, and notified ImmuPharma of the outcome.

"ImmuPharma and Avion are delighted that the FDA are expediting the Type 'A' Meeting for early December," said chief executive officer Dimitri Dimitriou.

"We look forward to providing a further update to the market following confirmation from Avion of the FDA's guidance post this meeting."

At 1210 GMT, shares in ImmuPharma were up 21.18% at 13.3p.