AbbVie Files For FDA And EMA Approval Of Upadacitinib For Ulcerative Colitis

AbbVie (ABBV), on Thursday, announced that it has submitted applications to the FDA and European Medicines Agency, pursuing expanded approval for Upadacitinib.

The company is seeking approval for Upadacitinib (15 mg and 30 mg (maintenance dose) and 45 mg (induction dose)) for the treatment of adults with moderately to severely active ulcerative colitis from the two regulatory agencies.

Upadacitinib, under brand name RINVOQ, in dosage of 15mg is already approved by the FDA for adults with moderately to severely active rheumatoid arthritis. RINVOQ 15 mg also is approved in the EU for adults with moderate to severe active rheumatoid arthritis, adults with active psoriatic arthritis (PsA), adults with active ankylosing spondylitis (AS), and adults and adolescents 12 years and older with moderate to severe atopic dermatitis (AD).

RINVOQ 30 mg is approved in the EU for adults with moderate to severe atopic dermatitis under age 65.

The drug generated global net revenue of $731 million in full-year 2020 and $681 million in the first half of 2021.

Commenting on the regulatory filings, Tom Hudson, senior vice president of research and development, chief scientific officer, AbbVie, said, "Upadacitinib has the potential to be an important new treatment option for people with ulcerative colitis, who want to address these challenging and disruptive symptoms. We look forward to working with regulatory authorities and hope to bring upadacitinib to people with ulcerative colitis as quickly as possible."

ABBV has traded in the range of $79.11 to $121.53 in the 52-week period. It is currently trading at $107.59, down $0.18 or 0.17 percent from previous close.

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