Former Leo Pharma candidate heads into big study as FDA fast-tracks assessment
Union Therapeutics is preparing a large-scale phase IIb trial to test its candidate orismilast within atopic dermatitis. On Thursday, the FDA fast-tracked the drug, potentially saving the biotech company "several months" in a potential approval case processing, the company's CFO says.
BY ALBERT RØNNING-ANDERSSON, TRANSLATED BY DANIEL PEDERSEN AND CATHERINE BRETT
Acquiring drug candidate orismilast from Leo Pharma in summer of last year in a deal valued up to DKK 1.2bn (USD 186.4m) has turned out to be a good decision for Union Therapeutics.
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