TARRYTOWN, N.Y. - The U.S. Food and Drug Administration (FDA) has expanded the approval for Dupixent® (dupilumab) to include adolescent patients aged 12 to 17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP), as announced by Regeneron (NASDAQ:REGN) Pharmaceuticals, Inc. and Sanofi (NASDAQ:SNY) on September 13, 2024. This decision follows the initial approval for patients aged 18 and older in June 2019.
CRSwNP is a chronic inflammatory condition of the sinuses and nasal passages that can significantly impact breathing, sense of smell and taste, and overall quality of life. While systemic steroids and surgery are standard treatments, they often fail to fully control symptoms and can lead to the recurrence of nasal polyps.
The FDA granted Dupixent Priority Review, a status for drugs that could offer significant improvements in treatment safety or efficacy. The approval is based on results from two pivotal adult trials, SINUS-24 and SINUS-52, which showed Dupixent significantly improved nasal congestion/obstruction severity, nasal polyp size, sense of smell, and reduced the need for systemic corticosteroids or surgery at 24 weeks compared to placebo.
Dupixent's safety profile in adolescents was consistent with that observed in adults and across its approved indications. Common adverse events included injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.
Regeneron and Sanofi have made Dupixent available through the DUPIXENT MyWay® program, which provides access and support to U.S. patients prescribed the drug. Dupixent is a monoclonal antibody that inhibits the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), key drivers of type 2 inflammation, which plays a significant role in CRSwNP and other related diseases.
With this approval, Dupixent becomes the first biologic specifically indicated for adolescents with CRSwNP, offering an alternative to the current standard of care. The drug has been approved in over 60 countries for various indications and is currently being used to treat more than 1 million patients globally.
The information in this article is based on a press release statement from Regeneron Pharmaceuticals, Inc.
In other recent news, Regeneron Pharmaceuticals has showcased notable advancements and financial growth. The company reported a 12% increase in total revenues to $3.55 billion, largely driven by solid product sales. Eylea HD sales in the U.S. held a 45% market share with $304 million in earnings, while Dupixent global revenues surged by 29% to $3.56 billion. BMO Capital maintained an Outperform rating on Regeneron's stock, following the release of new data from the Dupixent trial in Chronic Spontaneous Urticaria (CSU). TD Cowen also reiterated a Buy rating, highlighting the successful clinical trial results for Dupixent. Meanwhile, RBC Capital recognized the potential in Regeneron's Factor XI program, which is swiftly advancing through the development pipeline. However, the company is currently facing a potential delay in FDA approval for its linvoseltamab treatment and is undergoing a DOJ investigation into its marketing practices for Eylea. Despite these challenges, Regeneron has adjusted its full-year 2024 financial guidance, now expecting a gross margin of approximately 89%.
InvestingPro Insights
Following the FDA's approval to extend the use of Dupixent® to adolescent patients, Regeneron Pharmaceuticals, Inc. has showcased its potential for growth in the biotechnology sector. According to InvestingPro, Regeneron is not only a prominent player in the industry but also operates with a moderate level of debt, which suggests a stable financial footing for pursuing such expansions in its drug portfolio. The company’s prudent financial management is further underscored by its ability to cover interest payments with its cash flows and the fact that its liquid assets exceed short-term obligations.
InvestingPro data reveals that Regeneron has a market capitalization of $125.11 billion and trades with a price-to-earnings (P/E) ratio of 28.77, reflecting investor confidence in its earnings potential. Additionally, the company's revenue growth over the last twelve months as of Q2 2024 stands at 6.46%, indicating a steady upward trajectory. While Regeneron's stock generally trades with low price volatility, it is also trading near its 52-week high, which points to a robust market performance.
For those interested in deeper analysis, InvestingPro offers additional insights on Regeneron, including a total of 12 InvestingPro Tips, which can be accessed at https://www.investing.com/pro/REGN. These tips provide valuable perspectives on the company's valuation, profitability, and market performance, which are essential for making informed investment decisions.
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