June 16, 2020

The U.S. FDA has approved a new indication for Cosentyx® (secukinumab), manufactured by Novartis, to treat adults who have active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

Axial spondyloarthritis affects an estimated 2.7 million in the United States and is believed to be significantly underdiagnosed. The effects of the condition include inflammatory arthritis of the spine and chronic back pain. In nr-axSpA, there is no damage to the spine visible on X-rays. Over time, the condition can progress and become ankylosing spondylitis, where fusion of the spine becomes visible on X-rays.

In a clinical study, patients who received Cosentyx experienced a significant reduction in disease activity compared to those who received a placebo. Patients on Cosentyx also had a greater improvement in general health status and quality of life than those on placebo, based on results of two surveys designed to assess these factors.

Recommended dosing under the new indication is 150mg once every four weeks, administered via subcutaneous injection, when begun without a loading dose. If a loading dose is needed, Cosentyx should be administered once a week for the first five weeks, then once every four weeks thereafter. Patients have the option to self-administer Cosentyx once properly trained in its use.

Originally FDA approved in 2015, Cosentyx is also indicated to treat plaque psoriasis, psoriatic arthritis, and active ankylosing spondylitis.

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