With Baricitinib, Lilly Hopes To Succeed Where Pfizer Has Struggled
With data demonstrating superiority to Humira and likely lower pricing than anti-TNF drugs, baricitinib may be poised to make more of an impact than Pfizer has with its JAK inhibitor Xeljanz.
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FDA complete response letter seeks additional data on dosing and other safety concerns, delaying potential approval for an NDA that already had been pushed back three months. Interleukin-6 inhibitors sarilumab and sirukumab, now under review at FDA, both could obtain approval before baricitinib.
Keeping Track: Trulance Is First Novel Drug Of 2017; Vantrela ER Is Year's Second Abuse-Deterrent Opioid
The latest drug development news and highlights from our FDA Performance Tracker.
At ACR: Janssen reported data that show Celltrion’s Remicade biosimilar is not quite the same, but positive sirukumab results may not boost the Janssen and GSK biologic’s market prospects. Meanwhile, Corbus surged on mid-stage resunab results in systemic sclerosis, Janssen shared Phase II gesulkumab psoriasis results, Genentech eyes a new Actemra indication, and Xencor rose on interim Phase II data.