The benefits of Novartis AG's anti-inflammation drug outweighed the risks in using it to treat a type of psoriasis, staff reviewers at the U.S. Food and Drug Administration said.
The injectable biologic, secukinumab, is part of an eagerly anticipated class of drugs called IL-17 inhibitors that have shown unprecedented success in treating patients with plaque-psoriasis, the most common form of the painful skin condition.
A biologic is a protein-based drug derived from living cells cultured in a laboratory.
Secukinumab, or AIN457, is expected to be the forerunner in this kind of immunosuppressant therapy. This class of drugs targets the inflammation-causing protein interleukin-17 (IL-17) that play a central role in psoriasis and other inflammatory conditions.
The review was posted on the FDA's website on Thursday, four days before a panel of outside advisers is scheduled to meet.
While the FDA is not obligated to accept the recommendations of the panel, it typically does so.
The chronic autoimmune disorder, whose etiology is still unclear, accelerates skin cell growth by up to ten-fold, manifesting as raised, red, scaly patches on the skin and affects an estimated 125 million worldwide.
A head-to-head study with Amgen Inc's blockbuster Enbrel has shown secukinumab's superiority in treating plaque-psoriasis patients.
The FDA staff based its recommendation on the review of the data from this study, along with data from other trials.
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