FDA approves Uplizna as first IgG4-RD targeted therapy

THOUSAND OAKS, Calif. - Amgen (NASDAQ:AMGN), a prominent player in the biotechnology industry with a market capitalization of $166.46 billion and impressive revenue growth of 18.57% over the last twelve months, has announced that Uplizna (inebilizumab-cdon) has received approval from the U.S. Food and Drug Administration (FDA) as the first treatment for adults with Immunoglobulin G4-related disease (IgG4-RD). According to InvestingPro analysis, Amgen maintains a strong financial health score of GOOD, positioning it well for continued innovation in the pharmaceutical space. IgG4-RD is a rare, chronic inflammatory condition that can lead to fibrosis and organ damage. The approval is based on the results of the MITIGATE trial, which showed an 87% reduction in the risk of disease flares compared to placebo.

The MITIGATE trial, a randomized, double-blind, placebo-controlled study, provided evidence of Uplizna’s efficacy in reducing disease activity. During the 52-week trial, only 10.3% of participants receiving Uplizna experienced a flare, as opposed to 59.7% of those on placebo. With a robust gross profit margin of 68.71%, Amgen demonstrates strong operational efficiency in bringing such innovative treatments to market. For deeper insights into Amgen’s financial metrics and growth potential, InvestingPro subscribers have access to over 30 additional key metrics and exclusive analysis. Additionally, Uplizna demonstrated a significant reduction in the need for glucocorticoids, a common but potentially harmful treatment for IgG4-RD.

Jay Bradner, M.D., executive vice president of Research and Development at Amgen, highlighted the drug’s ability to target a key driver of the disease, potentially improving patient care by reducing flares and the reliance on long-term steroid use. The approval of Uplizna for IgG4-RD adds to its existing indication for the treatment of neuromyelitis optica spectrum disorder (NMOSD), first approved in June 2020.

John Stone, M.D., M.P.H., principal investigator of the MITIGATE trial and a professor at Harvard Medical School, emphasized the importance of this FDA-approved treatment in addressing the underlying mechanisms of IgG4-RD and controlling disease activity.

Uplizna’s safety profile was consistent with previous findings, with the most common adverse reactions being urinary tract infection and lymphopenia. Amgen has committed to supporting patients with IgG4-RD and facilitating access to Uplizna.

IgG4-RD is characterized by periods of remission and unpredictable flares, affecting multiple organ systems. CD19+ B cells are central to the disease’s pathophysiology, driving inflammatory and fibrotic processes. The estimated prevalence of IgG4-RD in the United States is around 20,000 people. The disease typically manifests between the ages of 50 and 70 and is more common in men. Investors seeking comprehensive analysis of biotech companies like Amgen can access detailed Pro Research Reports through InvestingPro, which provides in-depth coverage of 1,400+ US equities, including vital metrics, growth projections, and expert insights for informed investment decisions.

This news article is based on a press release statement from Amgen.

In other recent news, Amgen has reported a 19% year-on-year increase in product sales for 2024, driven by a diverse portfolio that includes several first-in-class medicines. Fitch Ratings has revised its outlook on Amgen to positive from stable, affirming the company’s Long-Term Issuer Default Rating at ’BBB’ and highlighting the potential for a future upgrade. This outlook is based on expectations that Amgen will continue to reduce its debt and increase revenues from new products. Additionally, Piper Sandler has maintained its Overweight rating on Amgen with a price target of $329, citing significant volume growth for key drugs like Repatha and Tezspire. Repatha saw a 44% increase in U.S. sales in 2024, despite a decrease in net pricing.

In the legal arena, a U.S. appeals court has denied Regeneron a stay on sales of biosimilar versions of its drug Eylea, allowing Amgen to potentially capture more market share with its biosimilar products. Amgen has also announced positive results from the Phase 3 MINT trial of UPLIZNA for generalized myasthenia gravis, showing sustained efficacy with twice-yearly dosing. The trial results are set to be presented at the American Academy of Neurology Annual Meeting in April 2025. Additionally, Amgen’s innovative R&D pipeline continues to show promise, with recent approvals and positive clinical data for several drugs.

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