Regeneron and Sanofi’s Dupixent FDA-approved for eosinophilic esophagitis

23-May-2022 - Last updated on 24-May-2022 at 13:33 GMT

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The approval is the first that the Food and Drug Administration has granted for a drug intended to treat eosinophilic esophagitis, a chronic immune disorder.

The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in adults and pediatric patients 12 years and older weighing at least 40 kilograms (which is about 88 pounds). The approval is the first granted to a treatment for EoE, which currently impacts about 160,000 patients in the US alone who are currently treated with therapies not specifically approved for the disease.

Jessica Lee, director of the Division of Gastroenterology in the FDA’s Center for Drug Evaluation and Research (CDER), said, “As researchers and clinicians have gained knowledge about eosinophilic esophagitis in recent years, more cases of the disorder have been recognized and diagnosed in the US. Today’s approval will fulfill an important unmet need for the increasing number of patients with eosinophilic esophagitis.”

EoE is a chronic inflammatory disorder where eosinophils (a type of white blood cell), are found in the tissue of the esophagus. Patients with EoE typically deal with a host of symptoms, including difficulty swallowing, difficulty eating, and food getting stuck in the esophagus. Dupixent (jointly developed by Regeneron and Sanofi) is a monoclonal antibody that acts to inhibit part of the inflammatory pathway.

“We have waited a long time for an FDA-approved treatment option for eosinophilic esophagitis, an underdiagnosed and misunderstood disease of the esophagus that can make it extremely challenging and uncomfortable to eat and swallow,” said Mary Jo Strobel, executive director of the American Partnership for Eosinophilic Disorders (APFED). “Before today, there were no approved treatments specifically for eosinophilic esophagitis, resulting in many people needing to maintain a strict diet and live in constant fear of food getting stuck in their throat. We welcome therapeutic options that can provide much-needed relief for these patients.”

George Yancopoulos, president and chief scientific officer of Regeneron, said, “Eosinophilic esophagitis can be debilitating for patients, by inflaming and damaging the esophagus and limiting the ability to eat normally. Dupixent is the first and only medicine specifically indicated to treat eosinophilic esophagitis in the US, and today’s approval marks the fourth disease for which Dupixent is now indicated, reinforcing the promise of targeting IL-4 and IL-13 to effectively treat diseases with underlying type 2 inflammation.”

Dupixent was studied in a randomized, double-blind, parallel-group, multicenter, placebo-controlled trial, that included two 24-week treatment periods (Part A and Part B) that were conducted independently in separate groups of patients. In Part A and Part B, patients received either a placebo or 300mg of Dupixent every week; Sanofi reports the patients receiving the drug showed notably more favorable results than those receiving a placebo.

John Reed, global head of R&D with Sanofi, said, “Our Phase III clinical program showed that Dupixent weekly improved the ability to swallow and reduced inflammation in the esophagus, underscoring the role of type 2 inflammation in this complex disease. This is a landmark FDA approval for patients and their caregivers who now have a new option for treating this devastating disease.”

The most common side effects associated with Dupixent include injection site reactions, upper respiratory tract infections, joint pain, and herpes viral infections. It is contraindicated in patients with known hypersensitivity to dupilumab or any of its inactive ingredients. Further, the drug holds certain warnings and precautions, including ones addressing the potential development of allergic reactions, conjunctivitis, keratitis, or joint pain; use in patients with certain parasitic infections; and use in conjunction with live vaccinations.

Dupixent was originally approved in 2017; it currently is approved for treating moderate-to-severe atopic dermatitis in adult and pediatric patients aged 6 and older whose disease is not adequately controlled by topical prescription therapies or when those therapies are not advisable. It also is also approved as an add-on maintenance treatment for adults and pediatric patients aged 6 and older with certain types of moderate-to-severe asthma, as well as an add-on maintenance treatment in adults with inadequately controlled chronic rhinosinusitis with nasal polyposis.