TARRYTOWN, N.Y. - Regeneron (NASDAQ:REGN) Pharmaceuticals, Inc. (NASDAQ:REGN) and its partner Sanofi (EPA:SASY) (NASDAQ:SNY) have announced the U.S. Food and Drug Administration's approval of Kevzara® (sarilumab) for treating children weighing at least 63 kilograms with active polyarticular juvenile idiopathic arthritis (pJIA).
This condition affects multiple joints and can cause severe pain, swelling, and long-term joint damage, potentially impacting a child's growth and development.
The FDA's decision is based on comprehensive studies and pharmacokinetic data derived from adult rheumatoid arthritis research, as well as a specific pediatric study on pJIA. The safety profile for children with pJIA was found to be consistent with that observed in adults with rheumatoid arthritis, with no new adverse reactions identified. Common side effects in the pJIA patient group included upper respiratory infections and reactions at the injection site.
Kevzara, an interleukin-6 (IL-6) receptor blocker, is already approved in 25 countries for adults with moderate to severe rheumatoid arthritis and in the U.S. for adults with polymyalgia rheumatica who have had an inadequate response to corticosteroids. The drug works by inhibiting the activity of IL-6, a protein that plays a key role in the inflammatory process of rheumatoid arthritis.
Regeneron and Sanofi are committed to ensuring that U.S. patients prescribed Kevzara have access to the medication and necessary support through KevzaraConnect®, a program offering assistance services throughout the treatment process. This includes support for uninsured patients, those without sufficient coverage, or those who require copay assistance.
This latest approval expands the treatment landscape for pediatric patients with pJIA, providing a new option with a proven track record of efficacy and safety. The companies emphasize their ongoing dedication to addressing the needs of younger patients facing chronic conditions like pJia.
The information reported is based on a press release statement from Regeneron Pharmaceuticals, Inc.
In other recent news, Regeneron Pharmaceuticals has seen its target raised to $1,200 by RBC Capital following an in-depth analysis of phase III studies for Dupixent, a treatment for conditions such as asthma and atopic dermatitis. This adjustment comes after comparing recent phase II results from competitors. RBC Capital has raised its Chronic Obstructive Pulmonary Disease (COPD) estimates for Dupixent, anticipating it to exceed $5.5 billion.
Despite a delay in the approval process of Dupixent for treating COPD by the U.S. Food and Drug Administration (FDA), BMO Capital maintains an outperform rating on Regeneron, predicting Dupixent to generate $2.9 billion in sales for the treatment of COPD. Piper Sandler also maintains its Overweight rating on Regeneron, adjusting its fourth quarter 2024 earnings estimate for Regeneron's Eylea franchise downward due to potential short-term challenges.
Evercore ISI initiated coverage on Regeneron, assigning an Outperform rating to the stock, highlighting the potential growth of Dupixent and sustained performance of Eylea. The FDA has also granted Priority Review for the supplemental Biologics License Application (sBLA) for Dupixent as an add-on maintenance treatment for adolescents aged 12 to 17 with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).
InvestingPro Insights
Regeneron Pharmaceuticals (NASDAQ:REGN) has recently garnered attention with the FDA's approval of Kevzara® for pediatric use, which may influence the company's market performance. Here are some insights based on current InvestingPro data and tips that could be valuable to investors following this development:
InvestingPro Data highlights Regeneron's robust market position with a significant market capitalization of $108.07 billion. The company's P/E ratio stands at 27.7, reflecting investor expectations for future earnings growth, which aligns with the company's P/E ratio for the last twelve months as of Q1 2024 at 25.5. Additionally, Regeneron has demonstrated revenue growth of 5.9% over the last twelve months, indicating a steady increase in its financial performance.
Two noteworthy InvestingPro Tips for Regeneron include the active share buyback management strategy, signaling confidence in the company's value, and the fact that analysts predict the company will be profitable this year. These aspects are particularly relevant as they suggest a stable financial outlook and potential for continued growth, especially with the expansion of Kevzara® into new patient demographics.
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