The U.S. food and Drug Administration approved a new drug on Tuesday to treat moderate to severe cases of eczema. Dupixent (dupilumab) is an injection intended for people whose eczema isn’t properly controlled by common topical treatments. The FDA granted Regeneron Pharmaceuticals, Inc. the application for Dupixent Priority Review and Breakthrough designation. This agency within Health and Human Services assures the safety and effectiveness of modern day medicines. It has now allowed Dupixent to be considered on drug formularies. However, there is currently no single price set and established for the drug.
Recent studies
Three trials that were controlled by placebos led the FDA to the sufficient security data they needed to approve dupilumab. More than 2,000 people participated in the study. The results confirmed that the drug reduced patient itching after 16 weeks and had clear skin while using drug versus using the placebo.
The director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research made a statement during the FDA approval of this drug. Julie Beitz, M.D. said, “FDA’s approval of Dupixent demonstrates our commitment to approving new and innovative therapies for patients with skin disease. Eczema can cause significant skin irritation and discomfort for patients, so it is important to have a variety of treatment options available to patients, including those patients whose disease is not controlled by topical therapies.”
Dupixent is currently being studied as a potential treatment for eczema in children.
The FDA approval stated on Tuesday only applies to the treatment in adults now. The new development is also being looked at as a solution to asthma, eosinophilic esophagitis and chronic sinusitis.
Drug cost to consumers
Dexipent is currently listed at a price of $37,000 a year. It is a twice-per-month injection that patients can do at home.
It’s manufacturers, Regeneron Pharmaceuticals and Sanofi, have noted that there will be sponsored programs that will help cover the cost of the medication.
Regeneron said, “Of the adults with uncontrolled moderate to severe atopic dermatitis in the United States, it is estimated that 300,000 are most in need of new treatment options.
The Wholesale Acquisition Cost of Dupixent in the Unites States is $37,000 annually. Actual costs to patients, payer and health systems are anticipated to be lower as WAC pricing does not reflect discounts, rebates or patient assistance programs.”
