FDA Approves Higher Cosentyx Dose for Active AS

The U.S. Food and Drug Administration (FDA) has approved a label update to Novartis’ Cosentyx (secukinumab), doubling the previously recommended dose to 300 mg for adults with active ankylosing spondylitis (AS).

“This approval gives clinicians added flexibility to ensure patients are able to achieve the best response to treatment and experience full relief from the signs and symptoms of AS,” Todd Fox, global head of medical affairs immunology, hepatology and dermatology at Novartis, said in a press release.

“It’s further encouraging news in our efforts to reimagine medicine across the axSpA [axial spondyloarthritis] disease spectrum,” Fox said.

axSpA is characterized by inflammatory back pain. It includes AS, in which joint damage is visible on X-rays, and non-radiographic axSpA, in which no changes can be seen on such scans.

Cosentyx is a fully human biologic therapy, meaning that it’s comprised of genetically engineered complex proteins, usually large in size, rather than small chemical agents.

The medication directly blocks interleukin-17A (IL-17A), a signaling molecule that drives inflammation and AS development.

The therapy was originally approved for doses of up to 150 mg based on two Phase 3 trials, MEASURE 1 (NCT01358175) and MEASURE 2 (NCT01649375). Both studies showed a substantial reduction in the signs and symptoms of AS after 16 weeks of treatment given by under-the-skin (subcutaneous) injection.

The FDA’s decision to approve the dose increase was based on data from the MEASURE 3 clinical trial (NCT02008916) — a three-year study of the efficacy and safety of 150 versus 300 mg doses of Cosentyx in people with active AS. A total of 226 adults received either dose, or a placebo.

The primary efficacy goal was the Assessment of SpondyloArthritis International Society (ASAS 20/40/50/70) response rate, which is defined as a 20% improvement or reduction in patient global assessment of disease, pain, function, and inflammation.

Both dosages met this primary goal, with response rates greater than those seen with a placebo. However, long-term data from MEASURE 3 showed that the benefits were greater in the 300 mg dose group, compared with the previously recommended 150 mg dose. Safety results were consistent with prior studies.

The European Commission, which regulates medications in the EU, had already approved the same label update in late 2019 . Besides AS, Cosentyx is indicated for the treatment of plaque psoriasis and psoriatic arthritis.

To date, more than 300,000 patients have been treated worldwide with Cosentyx, according to Novartis.