Sanofi (SNY)/Regeneron's Dupixent Meets Eczema Study Goal
Sanofi (SNY) and Regeneron (REGN)'s Dupixent meet all primary and secondary endpoints in phase III study to treat children aged six months to five yea...
Sanofi SNY and partner Regeneron REGN announced positive data from pivotal phase III study evaluating their blockbuster drug, Dupixent (dupilumab), to treat moderate-to-severe atopic dermatitis (“AD”) — also called eczema — in children aged between six months and five years.
The study evaluated the efficacy and safety of Dupixent combined with standard-of-care topical corticosteroids (“TCS”) versus TCS monotherapy (“placebo”) in 162 children aged between six months and five years with uncontrolled moderate-to-severe AD. The patients were administered the drug based on weight - 200 mg (children weighing between 5 kg and less than 15 kg), and 300 mg (children weighing between 15 kg and less than 30 kg).
The primary endpoints assessed the proportion of patients achieving an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear), and 75% improvement in Eczema Area and Severity Index (“EASI-75”) over a treatment period of 16 weeks. Data from the study demonstrated that treatment with the drug significantly reduced overall disease severity and improved skin clearance, itch along with health-related quality of life measures compared to placebo. While 28% patients achieved the primary endpoint — clear or almost-clear skin — compared to 4% with placebo, overall disease severity and itch reduced 70% and 49%, respectively.
Shares of Sanofi have risen 6.7% so far this year in comparison with the industry’s 15.8% rally.
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Shares of Regeneron have rallied 37.3% so far this year in comparison with the industry’s 0.7% growth.
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AD is a chronic type II inflammatory disease, and its symptoms include intense, persistent itch and skin lesions that can cover much of the body, resulting in skin dryness, cracking, redness or darkening, crusting and oozing along with increased risk of skin infections.
Dupixent is presently approved to treat moderate-to-severe AD in patients aged six years and older as well as two other type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis in adults and severe asthma in patients of 12 years and older in some countries including the United States.
We remind investors that per a global strategic collaboration agreement, Regeneron and Sanofi are jointly discovering, developing and commercializing fully human monoclonal antibodies including Dupixent, Kevzara as well as Libtayo.
Another popular medicine to treat eczema is Pfizer PFE’s Eucrisa, which is a topical treatment. Some companies have developed candidates like AbbVie’s ABBV Rinvoq, Lilly’s Olumiant and Pfizer’s abrocitinib, which are under review in the United States for the treatment of moderate to severe AD.
Regeneron Pharmaceuticals, Inc. Price
While Regeneron sports a Zacks Rank #1 (Strong Buy), Sanofi presently carries a Zacks Rank #3 (Hold).
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