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Pfizer’s Cibinqo granted FDA approval for adults with moderate-to-severe atopic dermatitis

The FDA based its approval on results from a clinical trial programme involving over 1,600 patients


Pfizer has announced that the US Food and Drug Administration (FDA) has granted approval for Cibinqo (abrocitinib) for the treatment of refractory, moderate-to-severe atopic dermatitis in adults whose disease is not managed with other therapies.

Cibinqo is a once-daily, oral Janus kinase 1 (JAK1) inhibitor used in adult patients living with moderate-to-severe atopic dermatitis who have not yet found relief in currently available treatment options, or for patients advised against using current treatments.

Atopic dermatitis is a chronic, debilitating skin condition characterised by skin inflammation and skin barrier irregularities. The condition is brought about, in part, by the individual’s abnormal immune response beneath the skin which is believed to contribute to inflammation within the skin, presenting with typical sign of atopic dermatitis on the surface.

Characterisations of atopic dermatitis include itching, thick or leathery skin, papulation and erythema, where patches of skin become discoloured.

Atopic dermatitis is one of the most common inflammatory skin conditions – affecting around 5-10% of adults living in the US, while 1 in 3 suffer with moderate-to-severe symptoms – and is often regarded as simply a skin rash.

“Atopic dermatitis is so much more than just a rash, and it goes beyond the surface of the skin. It’s a chronic condition that can both significantly disrupt patients’ daily lives and negatively impact their emotional well-being,” said Julie Block, president and CEO, National Eczema Association.

The FDA based its approval on the results gained from five clinical trials as part of a larger clinical trial programme involving more than 1,600 patients. The safety and effectiveness of Cibinqo was assessed in three randomised, placebo-controlled phase 3 trials, with the drug demonstrating a consistent safety profile.

Moreover, the results showed a profound improvement in skin clearance and a significant reduction in itching after a two week period for atopic dermatitis patients vs placebo.

Mike Gladstone, global president of Pfizer Inflammation & Immunology, said: “The FDA’s approval offers hope to the millions of patients across the US who are suffering daily with an immuno-inflammatory condition that can cause intense and persistent itching, pain, discomfort and distress if left uncontrolled.

“CIBINQO, an efficacious once-daily pill, is a medical breakthrough made possible by Pfizer researchers and the people living with moderate-to-severe atopic dermatitis who participated in our clinical trials,” he added.

Article by
Fleur Jeffries

17th January 2022

From: Regulatory



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