BRUSSELS/FRANKFURT/PARIS (dpa-AFX) - AbbVie Inc. (ABBV) announced Friday
that Friday that Risankizumab (SKYRIZI) has been recommended for European Union
approval for the treatment of adults with moderately to severely active
Ulcerative Colitis or UC.

The European Medicines Agency's Committee for Medicinal Products for Human Use
or CHMP adopted a positive opinion recommending the approval of risankizumab
(SKYRIZI) to treat adults with moderately to severely active UC who have had an
inadequate response, lost response, or were intolerant to either conventional or
biologic therapy.

The company noted that the recommended induction dose is 1200 mg intravenous or
IV, followed by a maintenance dose of 180 mg or 360 mg subcutaneous or SC, based
on individual patient presentation.

The final European Commission decision is expected in the third quarter of 2024.

UC is a chronic, idiopathic, immune-mediated inflammatory bowel disease or IBD
affecting the large intestine. It can lead to a substantial burden and often
results in disability.

Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie,
with AbbVie leading development and commercialization globally.

The CHMP's positive opinion is based on results from two pivotal Phase 3 trials,
INSPIRE and COMMAND, that evaluated the efficacy and safety of risankizumab in
adults with moderately to severely active UC.

In both trials, the primary endpoint of clinical remission and key secondary
endpoints, including endoscopic improvement and histologic-endoscopic mucosal
improvement, were met.

Edouard Louis, INSPIRE trial investigator, said, 'Results from the INSPIRE and
COMMAND Phase 3 trials show that patients with moderately to severely active UC
can strive for long-term management goals that go beyond symptom control,
including histologic-endoscopic mucosal healing. This finding is significant
since treatment goals for patients are evolving beyond symptom management to
include endoscopic remission.'

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