Regeneron-Sanofi Report Data on Dupixent in Atopic Dermatitis
Regeneron Pharmaceuticals, Inc. REGN and partner Sanofi SNY came up with positive detailed results from a phase III trial on Dupixent for the indication of atopic dermatitis in adolescents at in the 27th European Academy of Dermatology and Venereology (EADV) Congress in Paris, France.
The phase III trial evaluated the efficacy and safety of Dupixent monotherapy in adolescent patients with moderate-to-severe atopic dermatitis. Per the company, this is the first phase III trial of a biologic in this patient population. The trial enrolled 251 patients who were 12 years to 17 years of age with moderate-to-severe atopic dermatitis and whose disease could not be adequately controlled with topical medications or for whom topical treatment was medically inadvisable.
The results show that Dupixent monotherapy demonstrated a significant improvement in signs and symptoms of atopic dermatitis and certain quality of life measures in adolescent patients. The co-primary endpoint in international territories was 75% improvement in Eczema Area and Severity Index (EASI-75) at 16 weeks, while the same in the United States was the proportion of patients achieving Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear). The trial results show that 41.5% of patients who received Dupixent every two weeks and 38% of patients who received Dupixent every four weeks achieved 75% or greater skin improvement (EASI-75) compared to only 8% with placebo (p less than 0.001). Moreover, 24% of patients who received weight-based dosing of Dupixent every two weeks (200 mg or 300 mg) and 18% of patients who received a fixed dose of Dupixent every four weeks (300 mg) achieved the primary endpoint of clear or almost-clear skin as compared to only 2% with placebo.
We remind investors that Dupixent is currently approved for use in certain adult patients with moderate-to-severe atopic dermatitis in the United States and Europe. The results from this trial in adolescents form the basis of regulatory submissions for an approval in treating adolescents as well.
We note that strong Dupixent sales drove Regeneron’s impressive second-quarter results. Label expansion of approved drugs will further boost sales. The company and partner Sanofi are also working to expand Dupixent’s label, which should diversify the company’s revenue base and reduce dependence on the lead drug. Dupixent is being studied in asthma, adolescent and pediatric atopic dermatitis, nasal polyps, eosinophilic esophagitis (EoE) and grass immunotherapy. Further, additional studies on the drug have been planned in 2018.
Last month, the FDA has approved a supplemental Biologics License Application (sBLA) for Eylea injection in patients with wet age-related macular degeneration (wet AMD). Regeneron has co-developed Eylea with the HealthCare unit of Bayer AG BAYRY.
Regeneron’s stock has gained 4.3% in the year so far against the industry’s 4.7% decline.
Regeneron is working to expand its portfolio. The company and partner Pharmaceutical Industries Ltd. TEVA also announced positive top-line results from a phase III study on pipeline candidate, fasinumab in patients suffering from chronic pain from osteoarthritis (OA) of the knee or hip.
Regeneron currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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