FDA approves expanded use of Cibinqo for adolescents with atopic dermatitis
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The FDA has approved a supplemental new drug application to expand the use of abrocitinib for adolescents with atopic dermatitis when other systemic drug products are not adequate or advisable, according to a press release.
“Moderate to severe atopic dermatitis can have debilitating physical and emotional impacts on adolescents,” Angela Hwang, MBA, chief commercial officer and president of global biopharmaceutical business at Pfizer, said in the release. “As an efficacious, once-daily pill, we believe that Cibinqo offers an important new treatment option for adolescents burdened by uncontrolled symptoms of atopic dermatitis.”
Previously, abrocitinib (Cibinqo, Pfizer) was only approved for adults aged 18 years and older.
This expanded approval is based, in part, on data from the JADE TEEN phase 3 clinical trial, which included 285 adolescents aged 12 to younger than 18 years with moderate to severe AD.
Patients in the study were randomly assigned to receive 100 mg or 200 mg of abrocitinib or placebo once a day for 12 weeks while also on background topical therapy. At week 12:
- 39% of the patients on the 100 mg dose, 46% of those on the 200 mg dose and 24% of those on placebo achieved an Investigator Global Assessment response rate of 0 or 1.
- 64% of those on 100 mg, 71% of those on 200 mg and 41% of those on placebo achieved a 75% improvement in their Eczema Area and Severity Index scores.
- 13% of those on the 100 mg dose, 25% of those on 200 mg and 8% of those on placebo achieved at least a 4-point decrease from baseline in their Peak Pruritis Numerical Rating Scale scores.
Also, the researchers noted that the safety profile during JADE TEEN was consistent with other trials with adult populations, including five randomized placebo-controlled clinical trials and a long-term extension study with more than 1,600 patients treated with abrocitinib.
The most common adverse events across these studies included nasopharyngitis (12.4% with 100 mg, 8.7% with 200 mg and 7.9% with placebo), nausea (6% with 100 mg, 14.5% with 200 mg and 2.1% with placebo) and headache (6% with 100 mg, 7.8% with 200 mg and 3.5% with placebo).
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Perspective
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This approval adds another important tool to our toolkit for adolescents with uncontrolled moderate to severe atopic dermatitis — a group that is often very similar to adults but has fewer treatments because many are approved for adults exclusively or at least initially.
Abrocitinib has been a very successful therapy among adults, but because a fair number of my patients are aged younger than 18 years, I have not been able to utilize it in this group. This will allow me to gain experience in teens where there are still significant unmet needs.
We are in an incredibly exciting time for eczema. Each new medication and indication is another opportunity to talk to our patients, to see how they are doing and, for those who are not well-controlled, to offer the possibility of a new approach.
I have been very excited about a relatively new tool called the Atopic Dermatitis Control Tool. This validated six-question tool can help clinicians get a sense of disease control in our patients. It has been validated for patients aged 12 years and older, and I cannot tell you how many times I have had a patient say, “Whoa. I guess I’m not doing as well as I thought.”
In those moments, there is an opportunity to at least discuss other treatments or approaches, and that can be an extremely important juncture for patients.
Reference:
Atopic dermatitis control tool. https://www.adcontroltool.com/. Published July 2022. Accessed Feb. 12, 2023.
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