FDA Approves Novartis’ Psoriasis Drug
The US Food and Drug Administration (FDA) has approved Novartis’ Cosentyx (secukinumab), a drug to treat adults with moderate-to-severe plaque psoriasis. The FDA’s approval follows approval in the European Union by the European Commission earlier this month.
Secukinumab is an antibody that binds to a protein (interleukin (IL)-17A), which is involved in inflammation. By binding to IL-17A, secukinumab prevents it from binding to its receptor, and inhibits its ability to trigger the inflammatory response that plays a role in the development of plaque psoriasis. Cosentyx is administered as an injection under the skin. It is intended for patients who are candidates for systemic therapy (treatment using substances that travel through the bloodstream, after being taken by mouth or injected), phototherapy (ultraviolet light treatment), or a combination of both.
In addition to the US and EU, Cosentyx has been approved in Australia for the treatment of moderate-to-severe plaque psoriasis and in Japan for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis.
Cosentyx is also in Phase III development for psoriatic arthritis (PsA) and ankylosing spondylitis (AS); regulatory applications are planned for 2015.