Pfizer, FDA Delay Approval for Abrocitinib for Atopic Dermatitis


The FDA will also not meet the PDUFA date for tofacitinib for the treatment of active ankylosing spondylitis.

The US Food and Drug Administration (FDA) has alerted Pfizer they will not reach the goal Prescription Drug User Fee Act (PDUFA) date for abrocitinib, a potential treatment for adults and adolescents with moderate to severe atopic dermatitis.

The company announced on July 21 they would not meet the July 27 PDUFA date for the New Drug Application (NDA) for the oral small molecule drug that selectively inhibits Janus kinase (JAK) 1, which is believed to modulate multiple cytokines involved in the pathophysiology of atopic dermatitis, including interleukin 4 (IL-4), IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP).


Earlier this year, abrocitinib appeared superior to dupilumab in reducing itch of atopic dermatitis, while the agents were comparable and superior to placebo in other treatment outcomes, in the phase 3 JADE COMPARE trial.

The treatment was compared to placebo and to the subcutaneously administered anti-interleukin-4-receptor α monoclonal antibody, dupilumab, which is currently approved for the treatment of atopic dermatitis.

Researchers, led by Thomas Bieber, MD, PhD, Chair, Department of Dermatology and Allergy, Christine Kühne-Center for Allergy Research and Education, University of Bonn, reported an IGA response at week 12 in 48.4% of patients in the 200mg abrocitinib group; 36.6% in the 100mg abrocitinib group, 36.5% in the dupilumab group; and 14% of those receiving placebo. The EASI-75 response at week 12 was observed in 70.3%, 58.7%, 58.1% and 27.1%, respectively.


Pfizer also announced they would not meet the PDUFA date for a supplemental New Drug Application (sNDA) for tofacitinib (XELJANZ/XELJANZ XR), a treatment for adults with active ankylosing spondylitis due an ongoing post-marketing safety study evaluating the treatment in rheumatoid arthritis patients.

“We remain confident in the benefit-risk profiles of abrocitinib and XELJANZ, both of which have been demonstrated in robust clinical trial programs,” said Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development, in a statement. “For people who are suffering with moderate to severe atopic dermatitis or active ankylosing spondylitis, many have limited treatment options. We look forward to hearing from the FDA as we work to bring these important potential treatment options to the appropriate patients.”

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