FDA Panel Unanimously Backs Novartis AG' Psoriasis Drug
October 21, 2014
By Riley McDermid, BioSpace.com Breaking News Staff
Novartis has won a stamp of approval for its pioneering psoriasis drug secukinumab after the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the U.S. Food and Drug Administration (FDA) said late Monday that the benefits to patients are undeniable.
The panel 7 to 0 to support the approval of AIN457 (secukinumab), a selective interleukin-17A (IL-17A) inhibitor, for the treatment of moderate-to-severe plaque psoriasis. The injectable biologic is now approved for use in adult patients who are candidates for systemic therapy (a drug that is absorbed into the bloodstream and distributed to all parts of the body) or phototherapy (light therapy).
The panel based its recommendation data from 10 psoriasis Phase II/III clinical studies which included nearly 4,000 patients with moderate-to-severe plaque psoriasis.
The market Novartis hopes to capture with this drug is not insignificant: Earlier this year analysts at Kepler Chevreux projected secukinumab to achieve peak sales of $701 million in 2020. The company lauded the decision in a statement.
"Moderate-to-severe psoriasis is a serious condition where patients suffer from skin lesions that cause itching, pain and scaling. There is a need for novel therapies as not all treatments are appropriate or effective in every patient," said Vas Narasimhan, global head of development for Novartis Pharmaceuticals. "Today's recommendation is based on the efficacy and safety data put forth in our robust clinical trial program and brings us one step closer to delivering an innovative, new treatment option for people suffering from moderate-to-severe psoriasis. We look forward to working with the FDA as it finalizes its review."
The FDA is not required to accept a panel’s recommendations but it typically does so. A formal announcement will likely be made in coming months, if not sooner.
Novartis’s Phase III clinical program for secukinumab included four placebo-controlled pivotal studies which examined secukinumab 300 mg and 150 mg in patients with moderate-to-severe plaque psoriasis. In these studies, secukinumab met all primary and key secondary endpoints---and most importantly for patients, showed significant skin clearance at by week 12.
Most of those secukinumab-treated patients were still clear after a year of treatment, with marked lessening of the redness, scaling and thickness of psoriatic plaques, and fewer outbreaks in each region of the body.