For some patients, topical medication alone may be difficult to control atopic dermatitis. Such cases now have a new FDA-approved treatment plan, a biological drug from LEO Pharma that can solve chronic inflammatory skin diseases from the body.
U.S. Food and Drug Administration Tuesday Officially recognized The LEO drug tralokinumab is the latest in a series of regulatory approvals for the drug this year and is used to treat moderate to severe atopic dermatitis, also known as eczema. LEO, headquartered in Ballerup, Denmark, will market its new drug in the United States under the trade name “Adbry”.
LEO’s drug is an antibody designed to bind to and block interleukin 13 (IL-13), a signaling protein called cytokine that plays a key role in driving atopic dermatitis. Adbry is the first biologic drug approved by the FDA to target the disease.In order to obtain FDA approval, LEO will enter the U.S. market ahead of Eli Lilly. Eli Lilly is seeking IL-13 and lebrikizumab. Acquired Dermira for US$1.1 billion last year. Last week, the Indianapolis-based pharmaceutical giant Report Data from the third phase 3 study showed that its drug met all primary and secondary goals. Based on these results, the company said it plans to seek global regulatory approvals in 2023.
The FDA’s Adbry approval is based on the results of three Phase 3 studies that enrolled nearly 2,000 adults.exist preliminary result, LEO reported that the drug met its primary and secondary goals, which were measured by tests used to assess the severity of skin diseases.
LEO drugs are administered by subcutaneous injection, starting at a dose of 600 mg, and then 300 mg every other week. Side effects reported in clinical trials include upper respiratory tract infections, conjunctivitis and other eye problems, injection site reactions, and eosinophilia, which is a normal count of white blood cells called eosinophils. For patients weighing less than 100 kilograms (approximately 220 pounds), who get clear or almost clear skin after 16 weeks of treatment, a monthly dose of 300 mg can be considered.
IL-13 is one of several cytokines associated with atopic dermatitis. Partners Sanofi and Regeneron currently sell the blockbuster drug Dupixent, an antibody designed to block the IL-4 and IL-13 signaling pathways, both of which support the immune response generated in atopic dermatitis. Since it was approved for the treatment of atopic dermatitis in 2017, the drug has received more attention in asthma, and partners are also developing the drug for other indications. In the financial performance of the third quarter of this year, Sanofi reported that Dupixent’s revenue exceeded $1.4 billion, an increase of 55% compared to the same period last year.
Other new biologic drugs seeking the treatment of atopic dermatitis include Amgen, which was allied with Concord Kylin earlier this year Focus on the development of the Japanese company’s mid-term drug candidate KHK4083. The antibody treats the inflammatory response associated with atopic dermatitis by blocking OX40, a costimulatory receptor on activated T cells.
LEO added tralokinumab to its product line before 2016 trade With AstraZeneca. The pharmaceutical giant received US$115 million in advance to obtain global rights for skin disease molecules. AstraZeneca reserves the right to use the drug for indications other than skin diseases, including the asthma program currently underway.However, AstraZeneca reported in 2017 that the drug Phase 3 test failed In severe, uncontrolled asthma. AstraZeneca will still make money from this drug. Under the agreement with LEO, it is eligible to receive up to $1 billion in payments related to commercial milestones, as well as royalties for the Danish company to sell the drug.
Tralokinumab has been commercialized under the name Adtralza in the European Union, the United Kingdom, Canada and the United Arab Emirates. LEO said that its new drug is expected to be launched in the United States in February.
Anders Kronborg, Acting Chief Financial Officer of LEO, said in a prepared statement: “As our first biologic in the United States, Adbry marks our advancement in medical skin diseases. Significant progress has been made in the mission of learning nursing standards.”
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