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news.ImmuPharma's Lupus drug candidate, Lupuzor has received approval from the FDA to start the phase III as well as a 'Fast Track' designation.
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After filing IND (Investigational New Drug) with the FDA and the completion of the phase IIb study, the Company licensed the global rights of Lupuzor to Cephalon.
Following the move, Cephalon commenced an additional phase IIb study with a different formulation.
ImmuPharma recently regained rights to Lupuzor, due to the acquisition of Cephalon by Teva Pharmaceutical.
ImmuPharma CEO Dimitri Dimitriou said the company is happy about the development of Lupuzor and its approvals in the US, Europe and Japan regarding its progression to the final stage of testing.