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CHMP recommends Lilly psoriasis drug for approval

pharmafile | February 29, 2016 | News story | Research and Development Eli Lilly, Taltz, psoriasis 

Eli Lilly’s Taltz (ixekizumab) has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of moderate-to-severe plaque psoriasis, an important step for the drug towards full European approval.

The CHMP opinion was based on data from seven clinical trials, including three double-blinded multicentre Phase III studies. The CHMP positive opinion is now referred to the European Commission, from which Lilly says it expects a final decision within three months.

Taltz works by specifically targeting the cytokine interleukin IL-17A protein, which plays a key role in driving underlying inflammation in psoriasis. In the Phase III trials, about one third of patients receiving the drug had skin considered clear after three months on the medication. Releasing the results last year, Lilly revealed 78-90% of patients taking Taltz had at least a 75% improvement in their condition after the same period, as measured by the Psoriasis Area and Severity Index.

“Psoriasis is a serious, chronic disease that can also have a significant, and sometimes debilitating, psychological and social impact,” comments Andrew Hotchkiss, president for Lilly Bio-Medicines in Europe and Canada. “This CHMP positive opinion is a significant milestone in our quest to offer physicians a new therapeutic option for their patients with moderate-to-severe plaque psoriasis.”

Joel Levy

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