Jan. 8 Quick Takes: Alnylam’s vutrisiran headed for NDA after Phase III readout; plus AbbVie, DermBiont and FDA guidance

Alnylam’s vutrisiran meets Phase III amyloidosis endpoint
Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) will submit an NDA to FDA early this year for vutrisiran based on data from the open-label Phase III HELIOS-A study to treat hereditary TTR-mediated amyloidosis with polyneuropathy. The RNAi therapy met the primary endpoint evaluating change from baseline in the modified Neuropathy Impairment Score (mNIS+7) at 9 months relative to historical placebo data from the Phase III APOLLO trial of Onpattro patisiran.

Two Phase III successes for Skyrizi in Crohn’s
AbbVie Inc. (NYSE:ABBV) said Skyrizi risankizumab met the primary endpoints in the Phase III ADVANCE and MOTIVATE studies to treat moderate to severe Crohn’s disease. In both induction trials, the IL-23 inhibitor led to a higher proportion of patients who achieved clinical remission and endoscoptic response compared with placebo at week 12...