FDA Approves First Oral Treatment For Crohn's Disease, Making Seventh Approval For AbbVie's Rinvoq

The FDA approved AbbVie Inc's ABBV Rinvoq (upadacitinib) for moderately to severely active Crohn's disease patients with inadequate response or intolerance to one or more TNF blockers.

This is the seventh FDA approval for Rinvoq across rheumatology, dermatology, and gastroenterology, where it is now indicated in both ulcerative colitis and Crohn's disease.

The FDA noted that Rinvoq is the first oral drug. Though there are several other biologics already on the market to treat moderately to severely active Crohn's, including Johnson & Johnson's JNJ Stelara, Takeda Pharmaceutical Co Limited's TAK Entyvio and AbbVie's Skyrizi.

The approval was based on results from three studies, the U-EXCEED and U-EXCEL initial trial and the U-ENDURE maintenance trial, determining statistical significance in the co-primary endpoints of endoscopic response and clinical remission.

In AbbVie's most recent Q1 report, Skyrizi sales reached $1.36 billion, while Rinvoq had sales of $686 million.

Price Action: ABBV shares are down 0.06% at $143.35 during the premarket session on the last check Friday.

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