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The FDA approved AbbVie Inc's (NASDAQ: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.
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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 (NYSE:JNJ) Stelara, Takeda Pharmaceutical Co Limited's (NYSE: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.
Photo via Wikimedia Commons
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.