Tildrakizumab (Ilumetri) Gets EMA Panel Nod for Plaque Psoriasis

Megan Brooks

Disclosures

July 30, 2018

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended in favor of the interleukin (IL)-23 inhibitor tildrakizumab (Ilumetri, Almirall SA) for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

Tildrakizumab reduces the immune response and inflammatory process, leading to improvement in the signs and symptoms of plaque psoriasis, the EMA says in a press statement. The most common side effects are upper respiratory tract infections, gastroenteritis, nausea, diarrhea, headache, injection site pain, and back pain.

As previously reported by Medscape Medical News, in long-term extensions of two phase 3 trials (reSURFACE1 and reSURFACE2), more than 80% of patients with moderate to severe chronic plaque psoriasis treated with tildrakizumab for 2 years achieved a 75% reduction in Psoriasis Area Severity Index score, and adverse event rates were low.  

Once approved in Europe, tildrakizumab will be available as a 100-mg solution for injection. The drug should be prescribed by physicians experienced in the treatment of plaque psoriasis, according to the EMA.

The summary of product characteristics will include detailed recommendations for use of the product and will be published in the European public assessment report, which will be made available in all official European Union languages after the European Commission grants marketing authorization.

Last spring, the US Food and Drug Administration approved tildrakizumab-asmn (Ilumya, Sun Pharmaceuticals) for adults with moderate-to-severe plaque psoriasis who are eligible for systemic therapy or phototherapy.   

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