The European Commission has approved Eli Lilly’s biologic Taltz as a new treatment for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.
Taltz (ixekizumab) is an antibody specifically designed to target the cytokine interleukin IL-17A, a protein that plays a role in driving underlying inflammation in psoriasis.
Its approval comes on the back of data from seven clinical trials, including three pivotal double-blinded multi-centre Phase III studies (UNCOVER), which involved more than 3,800 psoriasis patients from 21 countries.
According to the data, for patients treated with the monoclonal antibody either every four weeks or every two weeks, between 78 percent and 90 percent achieved at least a 75% reduction in the Psoriasis Area and Severity Index score at 12 weeks.
Trial data also showed that 31 percent-41 percent of these patients achieved PASI 100, or clear skin, at week 12, compared to just 5 percent to 7 percent of those taking Pfizer/Amgen’s multi-billion-dollar anti-inflammatory Enbrel (etanercept).
Psoriasis, which can occur on any part of the body and is linked with other serious health conditions, such as diabetes and heart disease, affects up to 1.8 million people in the UK, around 20 percent of whom have moderate-to-severe plaque psoriasis.
The disease can have “a profound, detrimental impact on a person’s quality of life,” said Professor Christopher Griffiths, Foundation Professor of Dermatology, University of Manchester, noting that Taltz’ approval will offer patients a new biological treatment option.
The drug was approved by US regulators in March.
DAILY NEWS | APRIL 27, 2016