The US Food and Drug Administration (FDA) has approved AbbVie’s supplemental new drug application, updating the indication statement for Rinvoq (upadacitinib) to treat inflammatory bowel disease.
This approval relates to the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD).
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AbbVie’s revised indication permits the use of the therapy for patients who have undergone at least one approved systemic therapy, when tumour necrosis factor (TNF) blockers are deemed clinically unsuitable.
Rinvoq was previously indicated for adults with moderately to severely active UC or CD who had not responded adequately or were intolerant to one or more TNF blockers.
AbbVie global immunology clinical development head and vice-president Kori Wallace stated: “At AbbVie, we are committed to addressing the ongoing needs of patients living with inflammatory bowel disease. Ulcerative colitis and Crohn’s disease can impact every aspect of a patient’s life.
“This label update gives healthcare providers the option to prescribe RINVOQ for patients with moderately to severely active inflammatory bowel disease after the use of one approved systemic therapy if TNF blockers are deemed clinically inadvisable by the prescribing physician.”
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By GlobalDataRinvoq is a Janus kinase (JAK) inhibitor currently under investigation for a range of immune-mediated inflammatory diseases.
It is being evaluated in Phase III studies for conditions such as Takayasu arteritis, hidradenitis suppurativa, alopecia areata, vitiligo and systemic lupus erythematosus.
Rinvoq is also a prescription medicine for treating adults with moderate to severe rheumatoid arthritis, active ankylosing spondylitis, active non-radiographic axial spondyloarthritis with objective inflammation signs.
Other indications include active psoriatic arthritis, and giant cell arteritis when TNF blockers prove inadequate or intolerable.
