AbbVie, Pfizer’s JAK inhibitors get FDA clearance to treat atopic dermatitis

USA – The FDA has approved two once-daily, oral JAK inhibitors on for patients with moderate-to-severe atopic dermatitis whose disease is not well controlled with other systemic medications, including biologics, or when those therapies are contraindicated.

Pfizer’s Cibinqo (abrocitinib), which is indicated for use in adults, receives its first US approval, while AbbVie’s Rinvoq (upadacitinib), which is already approved in the country for rheumatoid arthritis and psoriatic arthritis, is now approved to treat atopic dermatitis in patients as young as 12.

Data from the Phase III Measure Up 1 and Measure Up 2 trials, which tested Rinvoq without topical corticosteroids, as well as the late-stage AD Up study, which evaluated the drug in conjunction with concomitant topical corticosteroid use, backed up AbbVie’s submission.

All three studies found that, when compared to a placebo, Rinvoq improved skin clearance and itching in adults and adolescents with the condition.

Meanwhile, Pfizer’s filing included data from the JADE MONO-1 and JADE MONO-2 studies, which compared Cibinqo monotherapy to placebo, as well as data from the JADE COMPARE trial, which included patients who were also receiving background topical therapy.

Cibinqo demonstrated statistically superior improvements in skin clearance, disease extent and severity, and rapid itch relief versus placebo.

In the Phase III JADE DARE trial, the drug also outperformed Dupixent (dupilumab) from Sanofi and Regeneron Pharmaceuticals on all efficacy measures.

Dupixent, which inhibits interleukin -4 (IL-4) and IL-13, saw a more than 50% increase in sales in the third quarter of 2021, reaching €1.4 billion (US$1.6 billion).

The FDA’s two decisions on come after review delays as the agency investigated safety concerns associated with the JAK inhibitor class.

It updated warnings and tightened restrictions on drugs in that class in September, including Rinvoq, Eli Lilly, and Incyte’s Olumiant (baricitinib), which is also being studied for atopic dermatitis.

Nonetheless, AbbVie recently reduced its Rinvoq 2025 forecast to US$7.5 billion as a result of the new US labeling restrictions, which is about US$500 million less than its previous estimate.

AbbVie reported that sales of its drug more than doubled to US$453 million in the third quarter of last year.

Cibinqo and Rinvoq have already been approved by EU regulators for the treatment of atopic dermatitis.

Meanwhile, the FDA approved Opzelura, a cream formulation of Incyte’s JAK1/JAK2 inhibitor ruxolitinib, for the short-term and non-continuous chronic treatment of mild-to-moderate atopic dermatitis in patients 12 years and older, last year.

Liked this article? Sign up to receive our regular email newsletters, focused on Africa and World’s healthcare industry, directly into your inbox. SUBSCRIBE HERE