FDA Approvals of Upadacitinib, Abrocitinib for Refractory Atopic Dermatitis Come With Boxed Warnings, Restrictive Labelling


The 2 drugs are the first small molecule JAK-1 inhibitors to be approved in the United States as treatment options for patients who are not responding to other therapies.

Despite some safety concerns and delays, officials with the FDA have approved the Janus kinase (JAK) inhibitors upadacitinib (Rinvoq; AbbVie) and abrocitinib (Cibinqo; Pfizer) for the treatment of refractory atopic dermatitis.

The 2 drugs are the first small molecule JAK-1 inhibitors to be approved in the United States as treatment options for patients who are not responding to other therapies. The approval could signify increased competition within the medication class, according to a press release from GlobalData.

“Although it is an exciting breakthrough for the atopic dermatitis space, these agents will not be used in the first line, as the labels say they should be used once all other therapy options are exhausted, including biologics, or when the use of certain therapies is inadvisable,” said Ramla Salad, a health care analyst at GlobalData, in the press release.

All of the doses were approved, including 15 mg and 30 mg doses for upadacitinib and 50 mg, 100 mg, and 200 mg doses of abrocitinib, despite initial concerns that only the lower doses would gain FDA approval. Patients receiving the therapies will need close monitoring due to specific FDA guidelines for each dose, including titration as needed.

Although abrocitinib’s recommended starting dosage is 100 mg, the 50 mg dosage was approved for patients with moderate renal impairment, patients receiving cytochrome P450 inhibitors or patients who are known or suspected to be poor metabolizers of CYP2C19. Patients with these considerations may increase their dosage up to 100 mg if they do not respond adequately to 50 mg, according to the press release.

“Pfizer may have a unique advantage due to the specific populations Cibinqo is targeting, and they will likely face little competition in these patients since competitors have not targeted these niche populations,” Salad said in the press release. “Rinvoq has a different advantage to Cibinqo as it is approved for use in both adults and adolescents (patients ages 12 years and older), whilst Cibinqo is just approved for adult use.”

Regardless, the FDA approvals will help solidify the JAK inhibitor class of therapies for atopic dermatitis, according to the press release. The approvals could also offer new options to patients who do not respond to already available therapies.

Earlier this month, the FDA approved abrocitinib as a once-daily oral treatment for adults with moderate to severe atopic dermatitis.


Rinvoq and Cibinqo Janus kinase (JAK) inhibitors approved by FDA with boxed warnings and restrictive labeling, says GlobalData. News release. GlobalData; January 25, 2022. Accessed January 25, 2022. https://www.globaldata.com/rinvoq-cibinqo-janus-kinase-jak-inhibitors-approved-fda-boxed-warnings-restrictive-labelling-says-globaldata/

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