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AbbVie (ABBV) on Monday said that the U.S. Food and Drug Administration has approved an update to the indication statement for its drug Rinvoq for the treatment of adults with moderately to severely active Inflammatory Bowel Disease.
Inflammatory Bowel Disease (IBD) refers to chronic conditions that cause inflammation and swelling in the digestive tract, with the main types being Crohn's disease (CD) and ulcerative colitis (UC).
Previously, RINVOQ was indicated for adults with moderately to severely active UC or CD who had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. The updated indication statement allows the use of the drug for patients after they have received at least one approved systemic therapy in the event TNF blockers are deemed clinically inadvisable by the physician.
ABBV shares rose 1% at the time of writing. On Stocktwits, retail sentiment around ABBV stock jumped from ‘neutral’ to ‘bullish’ territory over the past 24 hours, while message volume stayed at ‘low’ levels.
In the second quarter, Rinvoq was the second most revenue-generating drug from AbbVie’s portfolio after Skyrizi. Global Rinvoq net revenues were $2.028 billion in the three months, representing a year-over-year increase of approximately 42% on a reported basis.
Rinvoq is used to treat adults with moderate to severe rheumatoid arthritis, active psoriatic arthritis, moderate to severe ulcerative colitis, and Crohn's disease, among other conditions, in the U.S. It is also approved for the treatment of children 12 years of age and older with moderate to severe eczema.
Last month, AbbVie said that it does not expect any generic versions of its Rinvoq in the U.S. before April 2037 after settling litigation with all generic manufacturers that filed abbreviated new drug applications with the FDA for generic versions of Rinvoq.
ABBV stock is up by 31% this year and by about 19% over the past 12 months.
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