FDA. US: The U.S. Food and Drug Administration today approved Cosentyx
(secukinumab) to treat adults with moderate-to-severe plaque
psoriasis.
Psoriasis is a skin condition that causes patches of
skin redness and irritation. Psoriasis is an autoimmune disorder, and
occurs more commonly in patients in with a family history of the
disease, and most often begins in people between the ages of 15 and 35.
The most common form of psoriasis is plaque psoriasis, in which patients
develop thick, red skin with flaky, silver-white patches called scales.
Cosentyx’s
active ingredient is secukinumab. 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.
“Plaque psoriasis can cause significant skin
irritation and discomfort for patients, so it is important to have a
variety of treatment options available to patients,” said Amy Egan,
M.D., M.P.H., deputy director of the Office of Drug Evaluation III in
the FDA’s Center for Drug Evaluation and Research.
Cosentyx’s
safety and effectiveness were established in four clinical trials with a
total of 2,403 participants with plaque psoriasis who were candidates
for phototherapy or systemic therapy. Participants were randomly
assigned to receive Cosentyx or a placebo. The results showed that
Cosentyx achieved greater clinical response than placebo, with skin that
was clear or almost clear, as assessed by scoring of the extent, nature
and severity of psoriatic changes of the skin.
Cosentyx is being
approved with a Medication Guide to inform patients that, because
Cosentyx is a medicine that affects the immune system, patients may have
a greater risk of getting an infection. Serious allergic reactions have
been reported with the use of Cosentyx. Caution should be exercised
when considering the use of Cosentyx in patients with a chronic
infection or history of recurrent infection, and in patients with active
Crohn’s Disease. The most common side effects include diarrhea and
upper respiratory infections.
Cosentyx is marketed by East Hanover, New Jersey-based Novartis Pharmaceuticals Corporation.
The
FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is
responsible for the safety and security of our nation’s food supply,
cosmetics, dietary supplements, products that give off electronic
radiation, and for regulating tobacco products.