CHMP recommends approval of Ilumetri in plaque psoriasis.- Almirall.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ilumetri (tildrakizumab), from Almirall, intended for the treatment of moderate to severe plaque psoriasis. Ilumetri will be available as a 100- mg solution for injection. The active substance of Ilumetri is an interleukin inhibitor that acts as an immunosupressant by inhibiting the action of interleukin 23, thus reducing the release of proinflammatory cytokines.
The benefits with Ilumetri are its ability to reduce the immune response and inflammatory process, and thereby improve the signs and symptoms of patients with moderate to severe plaque psoriasis. The most common side effects are upper respiratory tract infections, gastroenteritis, nausea, diarrhea, headache, injection site pain and back pain. The full indication is: "Ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy".
The FDA approved Ilumetri in March 2018. Tildrakizumab was licensed by Sun Pharma from Merck Inc. where it was known as MK 3222.
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