TARRYTOWN, N.Y. - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Dupixent (dupilumab) for the treatment of eosinophilic esophagitis (EoE) in children as young as one year of age in the European Union (EU). This recommendation by CHMP is for children who weigh at least 15 kg and have not responded to conventional therapy. The European Commission is anticipated to make a final decision on this recommendation in the upcoming months.
Dupixent, co-developed by Regeneron (NASDAQ:REGN) Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (NASDAQ:SNY), is already authorized for use in adults and adolescents aged 12 years and older with EoE in the EU. The new recommendation is supported by the EoE KIDS Phase 3 trial, which showed a significant number of children achieving histological disease remission at week 16 when treated with Dupixent, compared to a placebo. Caregivers also noted improvements in EoE signs and symptoms.
The safety profile for Dupixent in this trial was consistent with the known safety profile in adolescents and adults with EoE. The most common adverse events (AEs) observed in the trial included COVID-19, nausea, injection site pain, and headache.
EoE is a chronic, progressive disease that can severely impact a child's ability to eat and thrive, with symptoms often mistaken for other conditions. Dupixent, which inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, has been studied across more than 60 clinical trials involving over 10,000 patients for various chronic diseases driven by type 2 inflammation.
The use of Dupixent in children aged 1 to 11 years with EoE remains investigational in the EU and has not yet received approval. More than 1,000,000 patients globally are being treated with Dupixent for various indications. The information in this article is based on a press release statement.
In other recent news, Regeneron Pharmaceuticals has been making significant strides in its financial performance and product portfolio. The company reported a 12% increase in total revenues to $3.55 billion, bolstered by robust product sales. Dupixent global revenues surged by 29% to $3.56 billion, while Eylea HD sales in the U.S. held a 45% market share with $304 million in earnings. BMO Capital and TD Cowen have maintained Outperform and Buy ratings respectively, on Regeneron's stock, following the presentation of promising data from various clinical trials.
Regeneron's drug Dupixent has received expanded approval from the U.S. Food and Drug Administration to include adolescent patients with chronic rhinosinusitis with nasal polyps. This makes Dupixent the first biologic specifically indicated for these patients. Moreover, the company has made significant progress with its Factor XI program, recognized by RBC Capital for its market potential.
In terms of product development, Regeneron has fully acquired Libtayo, which has surpassed $1 billion in annual sales, demonstrating a potential for a robust and growing product line. The company is also anticipating upcoming Phase 3 data for the combination of Libtayo and fianlimab in treating first-line metastatic melanoma expected in 2025, and Phase 2 data for the same combination in first-line non-small cell lung cancer, anticipated in the fourth quarter of 2024.
Despite facing potential delays in FDA approval for its linvoseltamab treatment and a DOJ investigation into its marketing practices for Eylea, Regeneron has adjusted its full-year 2024 financial guidance, now expecting a gross margin of approximately 89%. These developments mark significant milestones for the company in recent times.
InvestingPro Insights
As Regeneron Pharmaceuticals (NASDAQ: REGN) awaits the European Commission's decision on the expansion of Dupixent's use for treating eosinophilic esophagitis (EoE) in younger children, the company's financial health and market performance provide a broader context for evaluating its prospects. Regeneron's market capitalization stands at a robust $124.15 billion, reflecting investor confidence and the company's significance in the biotechnology sector. This is further supported by a Price/Earnings (P/E) ratio of 28.67, indicating a healthy valuation relative to earnings.
InvestingPro data shows that Regeneron has experienced a revenue growth of 6.46% over the last twelve months as of Q2 2024, demonstrating a solid upward trend in financial performance. This is complemented by a Gross Profit Margin of 53.27%, suggesting efficient operations and strong pricing power. With an Operating Income Margin of 30.14%, the company is effectively translating revenues into profits, which is crucial for long-term sustainability.
An InvestingPro Tip highlights Regeneron as a prominent player in the biotechnology industry, which is particularly relevant as the company seeks to broaden the application of its therapies. Another tip notes that the company operates with a moderate level of debt, ensuring that its financial structure supports continued investment in research and development—a key factor as it explores new indications for Dupixent.
For readers looking to delve deeper into Regeneron's financial and market performance, additional InvestingPro Tips are available, offering insights into aspects such as cash flow, asset liquidity, and analyst predictions for profitability. With a total of 11 InvestingPro Tips listed, interested parties can explore further by visiting https://www.investing.com/pro/REGN for a comprehensive analysis.
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