Sanofi and Regeneron Pharmaceuticals Drug Dupixent have won the approval of the FDA for chronic spontaneous urticaria, introducing a new approach to the treatment of this inflammatory skin disorder. It is the seventh indication approved by the FDA for the product of great success.
The regulatory decision announced on Friday covers the treatment of the patient age 12 years or more whose chronic symptoms of spontaneous urticaria (CSU) continue despite the treatment with standard antihistamines.
The CSU is partly driven by type 2 inflammation, a hyperactive immune type or response. This answer leads to hives and itching; CSU is a disease definite as a disease that lasts more than six weeks. Sanofi estimates that 1.7 million people in the US are affected by the CSU. Despite the wide availability of antihistamines, the company says that approximately half of patients with CSU have inadequate disease controlled by these standard treatments.
Antihistamines point to H1 receptors, receptors in immune cells that play a role in immune response and inflammation. The second -line treatment option for CSU is Xolair of Genentech, a asthma drug that expanded its approval to the inflammatory skin disorder in 2014. Xolair is an antibody designed to block immunoglobulin E receptors, which are involved. Involved. But other roads play a role in CSU. Dupixent, an injection-administered drug every two weeks, is a monoclonal antibody designed to block the IL-13 and IL-4 signage roads.
Dupixent FDA approval in CSU is based on the results of two phase 3 tests that evaluated the medication as a complement to antihistamines, compared to a placebo and antihistamines. The results showed Dupixent with the primary and secondary objectives of reducing the severity of itching and the activity of itching and hive compared to the control arm at 24 weeks. The study of the study of the study also showed more probability or a well -controlled disease or a complete response at 24 weeks. In security, the results were consistent with Dupixent’s known security profile in their approved indications. The most common adverke event reported were the injection site reactions.
Dupixent was first approved in 2017 as a treatment for atopic dermatitis. It is the best -selling product of Sanofi, which represents more than 13 billion euros (about $ 14.7 billion) in revenues in 2024. The inflammatory strategy and immunology of Sanofi includes the expansion of the use of the medication to the indications of Othher. Last year, the European Drug Commission and the FDA approved Dupixent for chronic obstructive pulmonary disease.
“This approval of the FDA provides a new treatment option to help address the underlying drivers of the thesis of serious and recurring signs and symptoms,” said Alyssa Johnsen, head of global therapeutic areas, immunology and oncological development in Sanofi, in a Praared statement. “Dupixent has the potential to improve the results for patients with CSU who previously had limited treatment options.”
In 2023, the FDA rejected Sanofi’s initial application for the medication in CSU, asking for more clinical data to show efficiency. This presentation was based on two phase 3 studies, one of which failed to meet the main objective of the trial. The forwarding included data from a third phase test 3. Dupixent is approved for CSU in Japan, the United Arab Emirates and Brazil. The medicine is still under review in this indication in Europe and other markets around the world.
There are other companies that try to provide new approaches to the treatment of CSU. Celldex Therapeutics is found in the late clinical development in a late stage with Barzovolimab, a drug of antibodies designed to join the kit receiver in mast cells. Evommune aims to address the activation of mast cells with a small oral molecule, EVO756. When the startup released a financing of the C series of $ 115 million last October, he said that preliminary data from phase 2b in CSU in the first half of 2025.
But CSU drug research has also led to failures. In 2022, the third harmonic development suspended from an oral small molecule kit inhibitor after phase 1 data showed signs of potential liver toxicity. The company focused its focus on a small molecule of different kit blocking, THB335, which is currently preparing for the development of phase 2. But last week, Third Harmonic announced plans to dissolve the company and sell its assets, including THB335, returning cash to the shareholders.
Meanwhile, Allakos has fallen short in his effort to develop antibodies that inhibit mast cells. Last year, Allakos reported that his Lirantelimab drug did not exceed a placebo in a phase 2 test in CSU. Biotechnology focused on a different medication, AK006. But the failure of phase 1 of that medicine in January triggered the second corporate restructuring of biotechnology in the last year.
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