Keeping Track: US FDA Shoots Down Lilly's Baricitinib, Approves Neurocrine's Ingrezza
The latest drug development news and highlights from our FDA Performance Tracker.
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Echoing complaints of other recent complete response recipients, TherapeuticsMD charges that US FDA's request for 12-month safety data for the dyspareunia therapy TX004HR is not consistent with earlier communications with agency.
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.
A summertime battle is expected between Neurocrine and Teva once both companies get their tardive dyskinesia drugs on the US market, but Neurocrine's April 11 approval for Ingrezza without an FDA warning label is already giving the biotech an edge.