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An overview of some of the biggest articles in the dermatology field covered this week, including new breakthroughs in research.
HCPLive has highlighted a number of topics in the field of dermatology this week, and 3 major examples of these covered breakthroughs in atopic dermatitis treatment, PDUFA date changes, and new classifications by the US Food and Drug Administration (FDA).
The stories included here covered topics that may significantly impact patients facing inflammatory skin conditions, severe allergic sensitization, and even rare genetic diseases.
There have been a number of important developments in the dermatology field that have occurred recently, but these 3 represent major examples from this week.
1. “FDA to Require Labeling of Sesame in Packaged Products Due to Food Allergy”
In this article, the FDA’s decision to add sesame to the list of major allergens in the United States on its website was explained and a literature review was included.
The article also included notes on the FDA’s decision to require food product distributors to package food with correct labels with the word “sesame” included, instead of words alluding to sesame such as “natural flavor,” “spices,” or “tahini.”
The literature review covered several notable facts from prior studies, one being that anaphylaxis was initially observed as a result of sesame exposure in 37.5% of patients.
“One concerning finding in patients with sesame allergy is the rare use of epinephrine autoinjectors for moderate and severe reactions, even in patients who already possess these prescriptions at the time of initial presentation. With growing recognition of sesame as a potential cause of allergic reactions, we can hope that awareness of appropriate treatments will follow.”
This literature review was led by Samuel Weiss, MD, from the Wilford Hall Ambulatory Surgical Center Department of Allergy and Immunology.
2. “Lebrikizumab, Topical Corticosteroids Improved Outcomes for Atopic Dermatitis”
This article covered a study in which lebrikizumab was found—in combination with low-to mid-potency topical corticosteroids—to be more effective in treating moderate-to-severe atopic dermatitis (AD), compared with the group only treated with corticosteroids.
The study’s investigators noted that, prior to their research, they had realized that monotherapy would not always be feasible for AD patients in clinical settings.
Their research resulted from a desire to examine combining topical corticosteroids and biologic therapies as a means of treating moderate-to-severe AD.
“Lebrikizumab,a monoclonal antibody inhibiting interleukin-13, combined with (topical corticosteroids) was associated with reduced overall disease severity of moderate-to-severe AD in adolescents and adults, and had a safety profile consistent with previous lebrikizumab AD studies.”
The study’s research team was headed by Eric L. Simpson, MD, at Oregon Health & Science University’s Department of Dermatology.
3. “FDA Extends PDUFA Date for B-VEC Gene Therapy for Dystrophic Epidermolysis Bullosa”
This particular article covered the FDA’s decision to extend the PDUFA date for the topical gene therapy known as beremagene geperpavec (B-VEC), designed to treat dystrophic epidermolysis bullosa (DEB).
DEB is the rare genetic skin disorder also known as the ‘butterfly skin disease’ and is caused by COL7A1 gene mutations which then lead to everyday skin traumas, causing the skin to be as ‘delicate as a butterfly.’
B-VEC therapy’s PDUFA date was extended to May of 2023, due to Krystal Biotech, Inc.’s submission of an update on manufacturing information.
“While we are disappointed that this change was viewed as a major amendment, we are committed to working with the FDA as it completes its review of the B-VEC application. We will continue our commercial readiness efforts and upon approval bring this important treatment to DEB patients as soon as possible.”
The decision was announced in part by Krish Krishnan, the CEO and Chairman of Krystal Biotech, Inc.
View the full stories above to learn more about the biggest developments from HCPLive this week.