Amgen’s UPLIZNA becomes the first FDA-approved treatment for IgG4-related disease

Amgen has announced that the U.S. FDA has approved UPLIZNA (inebilizumab-cdon) as the first and only treatment for adults with Immunoglobulin G4-related disease (IgG4-RD), a chronic immune-mediated condition. The approval is based on results from the Phase 3b MITIGATE trial, which showed an 87% reduction in the risk of flares versus placebo. UPLIZNA also achieved corticosteroid-free, flare-free, complete remission in over half of treated patients. This marks UPLIZNA’s second approved indication, supporting Amgen’s expanding role in CD19+ B-cell targeted therapies for autoimmune diseases.

Amgen announced positive Phase 3 results from the MINT trial, showing UPLIZNA significantly improves symptoms in patients with generalized myasthenia gravis (gMG) who are acetylcholine receptor autoantibody-positive (AChR+). Over 52 weeks, patients receiving UPLIZNA experienced sustained symptom relief with just two doses per year. The findings will be presented at the American Academy of Neurology (AAN) Annual Meeting on April 8, 2025.

UPLIZNA showed a greater reduction in Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores compared to placebo. Among AChR+ patients, 72.3% had a ≥3 point improvement in MG-ADL scores versus 45.2% in the placebo group. Safety findings were consistent with its known profile.

UPLIZNA is currently approved for neuromyelitis optica spectrum disorder (NMOSD) and is under FDA review for Immunoglobulin G4-related disease (IgG4-RD). Regulatory filings for gMG treatment are expected to be completed in the first half of 2025.

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Amgen and Kyowa Kirin announced positive top-line results from the Phase 3 IGNITE study evaluating rocatinlimab, an investigational T-cell rebalancing therapy, for moderate to severe atopic dermatitis. The study met its co-primary and key secondary endpoints, showing significant improvements over placebo. At week 24, 42.3% of patients in the higher dose group achieved a 75% reduction in Eczema Area and Severity Index (EASI-75), while 23.6% had a clear or almost clear skin assessment (vIGA-AD 0/1). Safety results were consistent with prior findings, with the most common adverse events being fever, chills, and headache.

The ROCKET clinical program also includes the SHUTTLE study, which demonstrated efficacy when rocatinlimab was combined with topical treatments, and the VOYAGER study, which confirmed no interference with vaccine responses. Further trials, including ASCEND and ASTRO, will examine long-term effects and adolescent patients. Rocatinlimab, targeting the OX40 receptor, is being explored for other inflammatory conditions such as asthma and prurigo nodularis.

Amgen and Kyowa Kirin are jointly developing and commercializing rocatinlimab, with Amgen leading global efforts outside Japan. The findings will be presented at upcoming medical conferences.

Amgen (NASDAQ:AMGN) today announced that its Board of Directors declared a $2.38 per share dividend for the second quarter of 2025. The dividend will be paid on June 6, 2025, to all stockholders of record as of the close of business on May 16, 2025.

Amgen (NASDAQ: AMGN) reported its fourth-quarter and full-year 2024 financial results, showing strong growth in sales and earnings. For the fourth quarter, total revenues increased 11% to $9.1 billion, with product sales growing by 11%, driven by 14% volume growth. Notably, the company achieved $1.2 billion in sales from its rare disease products, including TEPEZZA, KRYSTEXXA, and UPLIZNA.

For the full year, Amgen reported a 19% increase in total revenues, reaching $33.4 billion. Product sales grew 19%, primarily due to a 23% increase in volume, partially offset by a 2% decrease in net selling price. Ten products delivered double-digit sales growth, with 21 products reaching record sales for the year.

However, Amgen’s GAAP earnings per share (EPS) decreased 18% in the fourth quarter to $1.16, and 39% for the full year to $7.56, primarily due to mark-to-market losses on equity investments and higher operating expenses, including those from the Horizon acquisition.

Non-GAAP EPS for the fourth quarter increased by 13%, reaching $5.31, and for the full year, it rose 6% to $19.84. Non-GAAP operating income also increased in both periods, but operating margins were impacted by higher expenses. The company generated $10.4 billion in free cash flow for the year, up from $7.4 billion in 2023.

Amgen continues to invest in its rapidly advancing pipeline, aiming to deliver innovative therapies across its therapeutic areas.

The U.S. Food and Drug Administration approved Amgen's combination therapy of Lumakras and Vectibix to treat advanced colorectal cancer in adults with specific KRAS and EGFR gene mutations. The treatment is for patients whose cancer has spread despite prior chemotherapy. The approval is supported by a late-stage study showing the therapy extended progression-free survival to 5.6 months, compared to two months with standard care.

Additionally, the FDA approved Qiagen's diagnostic device to identify eligible patients for this treatment. Colorectal cancer is the third most common cancer worldwide and the second leading cause of cancer-related deaths, highlighting the importance of such advancements in treatment.