The US Food and Drug Administration has given its stamp of approval to Eli Lilly’s Taltz as a new treatment for adults with moderate-to-severe plaque psoriasis.
Taltz (ixekizumab) is an antibody that binds to interleukin-17A, a protein that causes inflammation and plays a role in the development of the condition.
The drug is administered as an injection, and is intended for patients who are candidates for systemic therapy, phototherapy (ultraviolet light treatment) or a combination of both.
Safety and efficacy were established in three randomszed, placebo-controlled clinical trials with a total of 3,866 plaque psoriasis patients which showed that Taltz achieved greater clinical response than placebo, with skin that was clear or almost clear.
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).
The most common side effects reported include upper respiratory infections, injection site reactions and fungal (tinea) infections, but it can also cause serious allergic reactions and the development or worsening of inflammatory bowel disease, so patients should be closely for these conditions, the regulator stressed.