The EC approved Rinvoq based on positive data from induction studies, U-ACHIEVE induction and U-ACCOMPLISH, and a maintenance study, U-ACHIEVE maintenance

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AbbVie campus in Bay Area. (Credit: AbbVie Inc.)

US-based biotech company AbbVie has received the European Commission (EC) approval for RINVOQ (upadacitinib) to treat a type of ulcerative colitis in adult patients.

The drug is indicated for moderately to severely active ulcerative colitis in adults, with inadequate response or intolerant to either conventional therapy or a biological agent.

Rinvoq is a selective and reversible JAK inhibitor, discovered and developed by AbbVie.

It is currently being studied in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn’s disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis.

Rinvoq has been approved in several countries for indications including ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and atopic dermatitis.

AbbVie chief scientific officer and research and development senior vice president Thomas Hudson said: “Our years of experience and long-term investment in IBD research have given us invaluable insights into the challenges that ulcerative colitis patients face, and a deep understanding of the ongoing need for additional treatment options to help those still suffering.

“We celebrate today’s approval of Rinvoq by the EC as it meaningfully expands our ability to help indicated patients in need of relief from ulcerative colitis.”

The EC approved Rinvoq based on data from induction studies, U-ACHIEVE induction and U-ACCOMPLISH, and a maintenance study, U-ACHIEVE maintenance.

The two induction studies evaluated Rinvoq in 45mg strength, and the maintenance study in 15mg and 30mg doses.

In all the three ulcerative colitis trials, the drug showed statistical significance for the primary endpoint and met all the secondary endpoints.

The overall safety findings from the studies were consistent with the known safety profile of the drug, with no new important safety risks observed.

Last week, AbbVie received Health Canada’s approval for Rinvoq 15mg, to treat a type of active ankylosing spondylitis (AS) in adults.

The drug is indicated for AS in adults, with inadequate response to a biological disease-modifying anti-rheumatic drug (DMARD) or not eligible for those therapies.

Rinvoq is the first oral, once-daily selective and reversible JAK inhibitor approved in this indication, and can be used as monotherapy or in combination with NSAIDS, said AbbVie.