AbbVie's Rinvoq cleared in EU for atopic dermatitis
The FDA may be reluctant to trust JAK inhibitors, but the European Commission is more willing, and has just handed a first-in-class approval in atopic dermatitis to AbbVie's Rinvoq.
The EU regulator has cleared Rinvoq (upadacitinib) as an oral treatment for moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older, either with or without topical corticosteroid drugs.
It's a different story in the US, where the FDA first extended its review of the drug for atopic dermatitis by three months to mid-July, and then failed to deliver a verdict by the new deadline, as it has concerns about the safety of JAK inhibitors.
The agency has said it is waiting for further results from the ORAL Surveillance long-term, post-marketing safety study of Pfizer's JAK inhibitor Xeljanz (tofacitinib) in rheumatoid arthritis before deciding whether to approve new indications for drugs in the class.
That includes AbbVie's efforts to extend Rinvoq's approved US uses into atopic dermatitis as well as psoriatic arthritis and ankylosing spondylitis from its current indication in rheumatoid arthritis. In Europe, the drug is already marketed for the other three indications.
The ORAL Surveillance study is being carried out by Pfizer at the request of the FDA, after concerns emerged about the safety of Xeljanz, and specifically a possible increased risk of blood clots in the lungs and death.
In January, initial results pointed to an increased risk of cardiac side effects such as strokes and heart attacks than a control group treated with older, injectable TNF inhibitors.
All the JAK inhibitors currently carry warnings on their label about serious infections, malignancy and blood clots, and last year the FDA rejected Gilead Sciences' filgotinib outright.
It seems the EU regulator is not so concerned about the safety signal, clearing both 15mg and 30mg daily doses of Rinvoq for adults with atopic dermatitis, and a 15mg dose for adolescents and the over-65s.
AbbVie president Michael Severino said the approval is a "significant milestone" for the company and provides "an additional treatment option in Europe to help alleviate the burden of unrelenting itch and rash that many of these patients struggle with in daily life, despite available treatment options".
Rinvoq is also approved for atopic dermatitis in Russia, Saudi Arabia, United Arab Emirates, New Zealand and Chile.
The drug and another new immunology product – IL-23 inhibitor Skyrizi (risankizumab) – are AbbVie's main hopes of plugging the gap in its revenues caused by the start of biosimilar competition to its big-selling TNF inhibitor Humira (adalimumab).