An injected drug developed by Regeneron Pharmaceuticals Inc. in Westchester and its French pharmaceutical partner Sanofi to treat intense and often debilitating itching and widespread rashes that afflict an estimated 300,000 eczema patients in the U.S. has been approved for the market by the U.S. Food and Drug Administration, the companies jointly announced on Tuesday.
Marketed under the brand name Dupixent, the antibody drug dupilumab is the first biologic medicine approved for the treatment of adults with moderate to severe cases of atopic dermatitis whose disease is not adequately controlled by prescribed topical creams and ointments or when those treatments are not advisable.
The most common form of eczema, atopic dermatitis is a chronic inflammatory disease with symptoms often appearing as a rash on the skin. In moderate to severe cases, rashes often cover much of the body and come with persistent, often life-impairing itching and skin dryness, cracking, redness, crusting and oozing.
“People with moderate to severe atopic dermatitis cope with intense, sometimes unbearable symptoms that can impact them for most of their lives,” said Julie Block, president and CEO of the National Eczema Association, in the companies”™ announcement. With few options available to date to treat patients whose disease is uncontrolled, “That’s why today’s approval of Dupixent is so important for our community,” she said. “Now we have a treatment that is expected to help address patients suffering from this devastating disease.”
Patients can self-administer Dupixent, which comes in a syringe, with subcutaneous injections every other week after an initial loading dose by a physician. The antibody treatment can be used with or without topical corticosteroids, but should be not be taken by persons allergic to dupilumab or any of Dupixent”™s ingredients.
Regeneron and Sanofi Genzyme, the specialty care global business unit of Regeneron”™s Paris-based partner, will market the drug in the U.S. It is expected to be available to patients and providers later this week. In Europe, the drug last December was accepted for review by the European Medicines Agency for the same use by adult eczema patients there.
The drug”™s manufacturers said the wholesale acquisition cost of Dupixent in the U.S. is $37,000 annually. Actual costs to patients, payers and health systems are expected to be lower as wholesale pricing does not reflect discounts, rebates or patient assistance programs, according to Regeneron and Sanofi.
With the FDA approval, the companies have launched a specialized program to provide support and services to patients throughout the treatment process, including phone consultations with registered nurses and other specialists. The program, Dupixent MyWay, will help eligible patients who are uninsured, lack coverage or need assistance with their out-of-pocket costs.
At Regeneron headquarters on the Landmark at Eastview campus, Dr. George D. Yancopoulos, the company”™s founding scientist, president and chief scientific officer, in Tuesday”™s announcement said Dupixent “is the result of years of tireless research by our scientists into the underlying causes of allergic and atopic diseases. In atopic dermatitis, Dupixent was shown to help clear the skin and manage the intense itch caused by the disease.”
Those results came from the work of clinical investigators and participation of 2,119 patients in the global Liberty AD clinical program, which included three Phase 3 trials given priority review by the FDA. The FDA in 2014 designated Dupixent as a breakthrough therapy for the serious eczema condition, the first time that designation was granted for a dermatological disease other than skin cancers.
Last October, the FDA additionally designated Regeneron”™s dupilumab as a breakthrough therapy for children 6 months to 11 years old with severe atopic dermatitis and adolescents ages 12 to 17 with moderate to severe symptoms of the disease. Those potential uses are still under investigation.
Regeneron and Sanofi are also studying in clinical trials the safety and efficacy of dupilumab in treating other inflammatory diseases that include uncontrolled asthma, nasal polyposis and eosinophilic esophagitis.
At a November 2015 ceremony to mark Regeneron”™s opening of two new lab and office buildings on its campus in Mount Pleasant, Bedford attorney Austin Jacobson offered compelling and grateful testimony about the success of Regeneron scientists in developing the drug that arrives on the national market this week as Dupixent.
Afflicted by unrelieved atopic dermatitis, years of pain, severe chronic itching that made scratching “the equivalent of breathing” and a grotesque physical appearance fit for a starring role in “horror movies” left him suicidal, Jacobson told an audience that included Gov. Andrew Cuomo. Told by his physician about dupilumab, which was then in late-stage clinical trials, the lawyer was “as resistant as resistant can be,” but decided to try it.
“Within two hours of getting the drug, I knew I was on the pathway to a cure, Jacobson said. “Within a month after taking this drug, I went from 100 percent covered (with rash) to 100 percent cured.”
“You, without knowing it, saved my life,” Jacobson told Regeneron employees. “I have never once thought about suicide again. I”™m happy with my life because you guys gave it back.”
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