January 22, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff
Swiss biopharmaceutical company Novartis AG announced on Jan. 21 that the U.S. Food and Drug Administration has approved of secukinumab, marketed as Cosentyx, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are eligible for systemic therapy or phototherapy.
“The FDA‘s approval of Cosentyx signifies a turning point for psoriasis patients, who can now benefit from the first and only approved treatment targeting the IL-17 pathway, which is proven to play a key role in the development of plaque psoriasis,” said David Epstein, division head of Novartis Pharmaceuticals . “This important milestone will now allow patients to receive a treatment that has the proven ability to offer clear or almost clear skin.”
Cosentyx is the first approved psoriasis medication to selectively bind to IL-17A and inhibit the interaction of the IL-17A receptor. Phase III data showed that the drug was able to clear most or all of the skin in a majority of patients with moderate-to-severe plaque psoriasis.
The FDA made its decision after reviewing the safety and efficacy results of 10 Phase II and Phase III studies, including one that examined more than 3,990 patients. Psoriasis, a chronic immune-mediated disease, impacts 125 million people around the world. Research shows that IL-17A plays a critical role in the body’s immune response in disorders such as moderate-to-severe plaque psoriasis.
In the Phase III program for Cosentyx, the safety profile for the drug was favorable. It met all primary and secondary endpoints, including Psoriasis Area and Severity Index responses, showing skin clearance at Week 12.
The Use of Secukinumab by Patients
Novartis announced the results from its Phase III studies FEATURE and JUNCTURE back in March 2014, examining secukinumab for the treatment of psoriasis. The data showed that when administered with a pre-filled syringe or autoinjector pen, the drug showed high efficacy and patient satisfaction.
“It is important that people living with psoriasis, a chronic skin disease, have highly effective and safe treatments they can conveniently self-administer,” said Tim Wright, global head of development for Novartis.
In both studies, 300 milligrams of the drug was able to provide almost clear skin at Week 12. By Week 3 of the studies, patients had already started to see clearing skin compared to a placebo.
