March 30, 2020

The U.S. FDA has approved an expanded indication for Taltz® (ixekizumab) 80mg/mL injection, manufactured by Eli Lilly. The drug, which was previously approved for use only in adults, is now indicated to treat moderate to severe plaque psoriasis in patients who are at least six years old and are candidates for systemic therapy or phototherapy.

Plaque psoriasis is the most common form of psoriasis diagnosed in children. Approximately a third of all patients diagnosed with psoriasis in their lifetimes will first experience symptoms before the age of 20. A genetic autoimmune condition, psoriasis causes patches of thick, rough, skin that appears red or silver and can become itchy and painful. This happens because the body produces new skin cells too rapidly. Moderate-to-severe plaque psoriasis is defined as psoriasis that covers from 3-10% of the body (moderate) or more than 10% of the body (severe).

In a clinical trial, 89% of patients 6-17 years of age treated with Taltz had a 75% improvement from baseline on their Psoriasis Area and Severity Index score, compared to 25% of patients on placebo. Eighty-one percent of patients administered Taltz had a static Physician’s Global Assessment of clear or almost clear skin at Week 12 versus 11% of patients given a placebo. Recommended dosing for pediatric patients who have plaque psoriasis is based on the patient’s weight.

Originally FDA approved in 2016, Taltz is also indicated to treat adults who have ankylosing spondylitis or active psoriatic arthritis.

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