Regeneron (REGN), Sanofi (SNY) Confirm FDA Approves Dupixent as First Treatment for Adults and Children Aged 12 and Older with Eosinophilic Esophagitis
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Dupixent is the first and only medicine indicated to treat eosinophilic esophagitis in the United States; approval granted more than two months ahead of FDA's Priority Review action date
Dupixent 300 mg weekly significantly improved signs and symptoms of eosinophilic esophagitis compared to placebo in a Phase 3 trial, underscoring the role of type 2 inflammation in this complex disease
Eosinophilic esophagitis is a chronic, progressive inflammatory disease driven by type 2 inflammation that damages the esophagus and prevents it from working properly
Approval represents first indication for Dupixent in a gastrointestinal disease and fourth disease indicated overall
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) 300 mg weekly to treat patients with eosinophilic esophagitis (EoE) aged 12 years and older, weighing at least 40 kg. With this approval, Dupixent becomes the first and only medicine specifically indicated to treat EoE in the United States. A regulatory filing for EoE is under review by the European Medicines Agency, and submissions to regulatory authorities in additional countries are planned by the end of 2022.
"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 at 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."
EoE is a chronic inflammatory disease driven by type 2 inflammation that damages the esophagus and prevents it from working properly. For people with EoE, swallowing even small amounts of food can be a painful and worrisome choking experience. They are often left to contend with the frustration and anxiety of a constantly evolving list of foods to avoid, a poor quality of life and a higher risk of depression. In cases where EoE causes the esophagus to narrow, forced and potentially painful dilation (physical expansion) of the esophagus may be needed. In severe cases, a feeding tube may be the only option to ensure proper caloric intake and adequate nutrition. About 160,000 patients are living with EoE in the U.S. These individuals are currently treated with therapies not specifically approved for the disease, of whom approximately 48,000 continue to experience symptoms despite multiple treatments.
"It is gratifying that Dupixent, a medicine that we invented in our laboratories, is now approved in yet another disease marked by allergic or type 2 inflammation, namely eosinophilic esophagitis," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent. "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 United States, 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."
"Eating regularly throughout the day is essential, yet significant difficulty swallowing food is a common symptom for people living with eosinophilic esophagitis. This can be incredibly upsetting and often leads to fear of pain or choking with every meal, every day," said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. "A large unmet need exists for treatment options that can provide meaningful symptom relief. Our Phase 3 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 FDA approval is based on data from a Phase 3 trial with two parts (Part A and Part B) evaluating the efficacy and safety of Dupixent 300 mg weekly, compared to placebo, in patients aged 12 years and older with EoE, weighing at least 40 kg. After 24 weeks, patients treated with Dupixent 300 mg weekly experienced the following changes in Part A and Part B, respectively:
- 69% and 64% reduction in disease symptoms from baseline compared to 32% and 41% for placebo. Disease symptoms were measured by the Dysphagia Symptom Questionnaire (DSQ), where patients receiving Dupixent experienced a 21.9- and 23.8-point clinically meaningful improvement compared to 9.6- and 13.9-point improvement for placebo.
- Approximately 10 times as many patients achieved histological disease remission (peak esophageal intraepithelial eosinophil count of ≤6 eos/high power field [hpf]) compared to placebo: 60% and 59% compared to 5% and 6% of patients receiving placebo.
The safety results were generally consistent with the known safety profile of Dupixent in its approved indications. Pooled adverse events from Parts A and B that were more commonly (≥2%) observed with Dupixent than placebo were injection site reactions (38% Dupixent, 33% placebo), upper respiratory tract infections (18% Dupixent, 10% placebo), arthralgia (2% Dupixent, 1% placebo) and herpes viral infections (2% Dupixent, 1% placebo).
The FDA evaluated the Dupixent application under Priority Review, which is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.
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