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Lilly Says Safety Not A Factor In Dropping Lupus Development With Olumiant

 
• By Joseph Haas

The pharma also warns that an FDA complete response letter could be coming for its supplemental NDA to add atopic dermatitis to the JAK1 inhibitor’s label.

Indianapolis - Circa April 2016: Eli Lilly and Company World Headquarters. Lilly makes Medicines and Pharmaceuticals IV - Image
Lilly may be backing away from label expansion plans for Olumiant in atopic dermatitis

Eli Lilly and Company said on 28 January that it will cease development of oral JAK inhibitor Olumiant (baricitinib) in systemic lupus erythematosus (SLE) and may be nearing an impasse with the US Food and Drug Administration about a supplemental filing to add atopic dermatitis to the product’s label. For the atopic dermatitis indication, the pharma warned of the possibility of a complete response letter, with analysts suggesting that could end Lilly and partner Incyte Corporation's efforts with the drug in eczema.

Apparently, Lilly and Incyte’s lack of “alignment” with the FDA on the supplemental new drug application (sNDA) centers on the...

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