FDA Roundup of the Week: October 20

OCTOBER 20, 2017
Kevin Kunzmann
After a busy series of decisions, the US Food and Drug Administration (FDA) had a slow week. No New Drug Applications met the market outside of oncology pharmaceuticals, and some decisions showed the administration's more critical and deliberate standard of regulation. Catch up on all the action with the FDA Roundup of the Week:

FDA Approves Golimumab for 2 New Indications

The FDA approved the rheumatoid arthritis therapy for supplemental indications including psoriatic arthritis in adults with active ankylosing spondylitis. It is the only fully-human anti-tumor necrosis factor alpha therapy administered with a 30-minute infusion.

REVOLVE Trial for Crohn's Disease Canceled

Earlier this month, the administration’s Data Monitoring Committee recommended Celgene discontinue its REVOLVE trial and its extension (SUSTAIN), testing oral compound GED-0301 (mongersen) for CD. Mongersen is a Smad7 protein-decreasing oligonucleotide that was considered for CD therapy due to its impact on TGF beta-1 signaling.

FDA Advisory Committee Recommends Semaglutide

The once-weekly injection therapy for improved glycemic control in adults with type 2 diabetes was given unanimous 16-0 backing by the committee. The Novo Nordisk product is now expected to gain FDA approval and improve on liraglutide (Victoza).

Ingrezza Continues to Expand in TD Market

The first-ever approved drug for tardive dyskinesia has been granted a supplemental dosing indication. Valbenazine (Ingrezza) capsules are now approved for 80 mg, once-daily therapy paired with psychiatric medications.


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