FDA approves Pfizer's JAK1 inhibitor Cibinqo for atopic dermatitis

Pfizer announced today that the U.

Cibinqo is an oral small molecule drug that selectively inhibits JAK1, thereby modulating multiple cytokines involved in specific dermatitis pathology, such as IL-4, IL-13, IL-22 and TSLP

FDA approval is based on the results of 5 large-scale clinical trial programs, 3 of which are randomized, placebo-controlled Phase 3 clinical trials to evaluate its safety and efficacy; in addition, 2 trials are used to evaluate the drug safety

In the trial, Cibinqo demonstrated a sustained safety profile, with significant improvements in skin cleanliness, disease severity, disease severity, and rapid pruritus relief after two weeks of treatment

▲Abrocitinib molecular structure (Image source: Edgar181, Public domain, via Wikimedia Commons)

The FDA approved 100-mg and 200-mg doses of Cibinqo, with the latter recommended for patients who did not respond significantly to the 100-mg dose

"Many patients with chronic inflammatory skin diseases, such as moderate-to-severe atopic dermatitis, experience symptoms that cannot be controlled with current therapies, and that's what these patients face

FDA approves second new drug this year to treat atopic dermatitis

References:

[1] US FDA Approves Pfizer's CIBINQO® (abrocitinib) for Adults with Moderate-to-Severe Atopic Dermatitis, Retrieved January 14, 2022, from https:// Pfizer's Cibinqo snags FDA approval to challenge Sanofi and Regeneron's Dupixent in eczema, Retrieved January 14, 2022, from https:// approval-to-challenge-sanofi-and-regeneron-s