Psoriasis Drug Cleared by FDA

New Psoriasis Treatment Available After Successful Clinical Trials

Psoriasis is a chronic immune disease that affects around 7.5 million Americans alone, with 1 in 5 suffering from moderate-to-severe plaque psoriasis. Eli Lilly’s ixekizumab recently won FDA approval as a new treatment therapy for psoriasis.

Psoriasis Drug & the Clinical Research Trial

Last year in April, the autoimmune treatment met its main goals in a Phase III clinical research trial. The way the drug works is that ixekizumab, an antibody, blocks the interleukin-17A cytokine and thus lessens the autoimmune-caused inflammation.

Two doses were tested against the placebo in psoriatic arthritis patients, and both dosage groups each showed statistically significant results after the 24-week course. Ixekizumab also showed to beat out Amgen’s Enbrel in clearing plaque psoriasis. The study will continue to monitor ixekizumab’s long-term efficacy for 3 years.

Early this past February, Eli Lilly put in a request for approval through the European Medicines Agency, where they recommended it for approval, a process expected to take 3 months.

Alex Azar, president at Lilly USA, released in a statement, “many people living with plaque psoriasis are looking for another treatment option for this disease. With this FDA approval, we are proud to provide patients and dermatologists with a new choice that may provide significant improvement of psoriasis plaques.”

Next Steps for Eli Lilly

Following the FDA approval for Novartis’ Cosentyx drug, Lilly will continue to expand the psoriasis treatment market. Cosentyx received two additional approvals for its use in psoriatic arthritis and ankylosing spondylitis just this past January, and ixekizumab, to be sold with the marketed name Taltz, seems likely to obtain approval for psoriatic arthritis in the upcoming year as well.

“Today’s approval provides patients suffering from plaque psoriasis with another important treatment options to help relieve the skin irritation and discomfort from the condition,” said Dr. Julie Beitz, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.

Stay Up to Date on Clinical Trial News

FDA approvals like the one discussed above are always done conservatively, and after extensive testing and clinical trials have been taken into consideration. Therefore, having Novartis’ treatment obtain FDA approval is a significant deal. To stay up to date on the latest news from clinical trials like this one as well as local clinical research trials, sign up for our newsletter today.