In trying to reach an agreement before approval, Dr. Miller said, “this is how the system is supposed to work.” 
 
 Christine Cramer, a spokeswoman for CVS Health, another leading pharmacy benefit manager, said, “While we believe our advocacy on behalf of our clients did ultimately influence Regeneron’s initial pricing strategy, the drug will be expensive.” 
 
 But Peter Maybarduk, director of the Access to Medicines program at Public Citizen, a consumer group, noted that negotiations still took place out of the public eye and within the context of a system that is inherently unfair. “It’s the arrangement that corporations found beneficial in a system that provides monopolies and rewards secrecy, and we should ask for considerably more as the standard,” he said. 
 
 Dupixent treats severe to moderate atopic dermatitis, a common form of eczema that goes beyond the occasional bouts of itchy, dry skin that many people get. For people with serious forms of the disease, other treatments often do little to calm their skin, leading to sleeplessness, depression and social anxiety. Regeneron said Tuesday that an estimated 300,000 people in the United States could qualify for its drug. 
 
 “I always say that atopic dermatitis doesn’t kill you, it just ruins your life,” said Dr. Elaine Siegfried, a professor of pediatrics and dermatology at the St. Louis University School of Medicine. She was not involved in the clinical trials that led to approval, but she said she was likely to enroll patients in pediatric studies that are getting underway. Dupixent, she said, appears to work well, with few serious side effects. “It is groundbreaking,” she said. 
 
 Debbie Byrnes, a sixth-grade teacher from San Antonio who participated in the clinical trial, had suffered for years with severe eczema that often covered her face. “That was the really difficult thing for me — I could never hide it,” she said. “I would have days when I went into school, and the kids would look at me and say, ‘What happened to you?’ ” 
 
 Ms. Byrnes said she began noticing a difference about five days after her first dose and has now been using the drug for two years. Her skin is now almost completely clear, and occasional flare-ups are quickly brought under control. “If you saw me,” she said, “you wouldn’t know that I ever had atopic dermatitis.” 

 Español 
 
 The U.S. Food and Drug Administration today approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupixent can be used with or without topical corticosteroids. 
 
 “FDA’s approval of Dupixent demonstrates our commitment to approving new and innovative therapies for patients with skin disease,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “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.” 
 
 Atopic dermatitis, a chronic inflammatory skin disease, is often referred to as “eczema,” which is a general term for several types of inflammation of the skin. Atopic dermatitis is the most common of the many types of eczema; onset typically begins in childhood and can last through adulthood. The cause of atopic dermatitis is a combination of genetic, immune and environmental factors. In atopic dermatitis, the skin develops red, scaly and crusted bumps, which are extremely itchy. Scratching leads to swelling, cracking, “weeping” clear fluid, and finally, coarsening and thickening of the skin. 
 
 Dupixent is administered as an injection under the skin. Dupixent’s active ingredient is an antibody (dupilumab) that binds to a protein [interleukin-4 (IL-4) receptor alpha subunit (IL-4R a )], that causes inflammation. By binding to this protein, Dupixent is able to inhibit the inflammatory response that plays a role in the development of atopic dermatitis. 
 
 The safety and efficacy of Dupixent were established in three placebo-controlled clinical trials with a total of 2,119 adult participants with moderate-to-severe atopic dermatitis not adequately controlled by topical medication(s). Overall, participants who received Dupixent achieved greater response, defined as clear or almost clear skin, and experienced a reduction in itch after 16 weeks of treatment. 
 
 Dupixent can cause side effects such as serious allergic reactions and eye problems, such as pink eye (conjunctivitis) and inflammation of the cornea (keratitis). If patients experience new or worsening eye symptoms such as redness, itching, pain or visual changes, they should consult a health care provider. The most common side effects include injection site reactions; cold sores in the mouth or on the lips; and eye and eyelid inflammation, including redness, swelling and itching. 
 
 The safety and efficacy of Dupixent have not been established in the treatment of asthma. Patients who also have asthma should not adjust or stop their asthma treatment without talking to their physicians. 
 
 The FDA granted the application for Dupixent Priority Review and Breakthrough Therapy designation. 
 
 The FDA granted the approval of Dupixent to Regeneron Pharmaceuticals, Inc. 
 
 The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The Agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. 
 
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 TRENTON, N.J. -- U.S. regulators have approved the first powerful, injected medicine to treat serious cases of the skin condition eczema. 
 
 The Food and Drug Administration on Tuesday approved Dupixent (dupilumab) for moderate or severe eczema, which causes red, fiercely itchy rashes on the face, arms and legs. 
 
 In three studies of the drug including a total of 2,119 participants, one-third to two-thirds achieved clear or nearly clear skin. About 4 in 10 had itching decrease sharply, bringing better sleep and reducing anxiety and depression. 
 
 Dupixent will have an initial list price of $37,000 per year, according to Paris, France-based Sanofi SA and Regeneron Pharmaceuticals of Tarrytown, New York, which developed the drug. 
 
 Side effects can include cold sores and inflammation of the eye and eyelid. 
 
 The drug is an antibody that patients inject just under the skin every two weeks. It binds to a specific protein to inhibit the immune system’s inflammatory response. That’s why in many study participants, Dupixent also improved the asthma and hayfever common in eczema patients. It’s now in late-stage patient testing as an allergy treatment. 
 
 Eczema treatments have generally been limited to topical medications, steroid creams, moisturizers and ultraviolet light, plus antihistamines to relieve itching. Those work fairly well for mild eczema, but not the severe -- and most common -- form, also called atopic dermatitis. 
 
 Because of that, analyst Jeffrey Holford of Jefferies LLC wrote Tuesday that “market expectations for Dupixent are high given the unmet need in this patient group,” with sales expected to climb slowly to about $3.4 billion in 2025. 
 
 Eczema often begins in young children, and most grow out of it, said Dr. Lisa Beck, a dermatology professor at the University of Rochester Medical Center in Rochester, New York. 
 
 For others, the condition persists throughout adulthood, tormenting patients with relentless itching that triggers scratching, and with that, skin swelling, cracking, “weeping” of clear fluid and, eventually, thickening of the skin, according to the FDA. 
 
 “Many of these patients gave up on health care because we offered them nothing new for years and years,” said Beck, a member of the National Eczema Association’s scientific advisory board who participated in patient tests of Dupixent, also called dupilumab. 
 
 “It was a true game-changer” for many patients, Beck said, greatly improving their skin and quality of life. 
 
 Ashley Blua, 29, of Hermosa Beach, California, participated in one study and still gets Dupixent in an ongoing follow-up study. 
 
 Blua, who’s had eczema her whole life, said her eczema became much worse three years ago, covering most of her body. She had trouble focusing at work due to sleep deprivation, despite numbing her body with ice packs at night to reduce itching. She tried every topical cream, kept multiple changes of clothes in her car for when her skin bleeding seeped through blouses, and had frequent visits with dermatologist, allergists, a therapist and a psychiatrist. 
 
 Several months after entering the study nearly two years ago, symptoms started easing. Now she only has only a few eczema patches — and no more itching. 
 
 “Now that I can live a normal life again, I’ve gotten engaged and we’re getting married in August,” says Blua. She’s even planning to wear a white, strapless wedding gown.
– The FDA just greenlighted a drug that keeps severe eczema at bay, but it comes with a price tag so steep it's eliciting its own sort of inflammatory response from critics. Dupixent could finally provide relief to people suffering from severe eczema—which goes beyond mere patches of itchy, dry skin and can cause sleeplessness, depression, and social anxiety—but it will run $37,000 a year. That's actually well below the $50,000 price tag of best-selling drugs Humira and Enbrel for skin diseases such as psoriasis, reports the New York Times. And this drug looks highly effective; in clinical trials, somewhere between one-third and two-thirds of participants enjoyed clear or nearly clear skin, reports CBS News. "Now that I can live a normal life again, I’ve gotten engaged and we’re getting married in August," says one study participant. The drug is administered by injection to treat adults with moderate to severe eczema using the antibody dupilumab, which binds to a protein that causes inflammation, thus preventing an outbreak. One teacher in a clinical trial tells the Times the drug started working in five days and has changed her life, while an unaffiliated dermatologist and pediatrician calls it "groundbreaking" for a condition that "doesn't kill you, but ruins your life." In an unusual move, the company that developed the drug, Regeneron, negotiated pricing directly with insurers. Most people with insurance won't have to pay the full price, but it's not unheard of to have to pay as much as half, or the full price until reaching one's deductible. "Right now they have the benefit of being alone," says one analyst. "But going forward, I think there will be a lot of price competition." (This cheap and simple product helps reduce eczema in babies.)