AbbVie obtains FDA nod for new indication of Rinvoq

AbbVie has received the Food and Drug Administration’s green light for Rinvoq (upadacitinib) for the treatment of moderate to severe atopic dermatitis in adults and children aged 12 years old and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines or when use of other pills or injections is not recommended.

"Early in my career as an allergist, I saw how relentless the itch and rash could be for my patients with moderate to severe atopic dermatitis yet had limited options to offer those whose disease could not be adequately controlled with systemic therapy," said Thomas Hudson, senior vice president, research and development, chief scientific officer, AbbVie. "This additional approval for Rinvoq provides a once-daily oral option that can significantly improve the debilitating itch and skin symptoms of atopic dermatitis. It's also a proud moment for AbbVie as we continue our efforts to improve care in this disease state and other chronic, immune-mediated conditions."

[Read more: FDA gives AbbVie approval for Qulipta]

Rinvoq 15 mg and 30 mg already is approved for use in adults and pediatric patients aged 12 years old and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.

Rinvoq 15 mg also is approved for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers as well as adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.