CHMP Supports Cosentyx’s Approval in Europe to Treat nr-axSpA
The Committee for Medicinal Products for Human Use (CHMP) is recommending the approval of Cosentyx (secukinumab) for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA).
Recommendations from CHMP, part of the European Medicines Agency, are typically accepted by the European Commission.
Axial spondyloarthritis (axSpA) is a kind of arthritis that predominantly affects joints in the spine. It is categorized as ankylosing spondylitis (AS) when joint damage is visible on radiographs (X-rays) and as nr-axSpA if no such changes are evident with this approach.
Cosentyx, developed by Novartis, is a biologic therapy that works by blocking the pro-inflammatory molecule interleukin-17a (IL-17a). This is intended to decrease arthritis-related inflammation. The therapy was approved to treat people with AS in Europe in 2015, and for the same indication in the United States the following year, but is not currently approved for patients with nr-axSpA.
If approved, Cosentyx would become the first fully human IL-17a inhibitor indicated for people with nr-axSpA in Europe.
“Non-radiographic axial spondyloarthritis is part of the axSpA spectrum and is a painful and debilitating disease for which there are limited treatment options available,” Eric Hughes, MD, PhD, global development unit head for immunology, hepatology, and dermatology at Novartis, said in a press release. “This positive opinion marks another step forward in our commitment to reimagine medicine in axSpA and help patients realize relief from the burdensome symptoms of their disease earlier.”
The CHMP opinion is based largely on a Novartis-sponsored Phase 3 trial (NCT02696031), called PREVENT.
The study recruited 555 adults with active nr-axSpA. Participants were experiencing ongoing inflammation (as evidenced by blood markers and/or magnetic resonance imaging) and had responded inadequately to nonsteroidal anti-inflammatory drugs, which include aspirin and ibuprofen.
They were randomly assigned to receive Cosentyx or a placebo. Cosentyx was given monthly at a dose of 150 mg via subcutaneous (under-the-skin) injections. Some participants on Cosentyx also received an induction phase consisting of 150 mg Cosentyx administered weekly for four weeks.
Efficacy was primarily assessed by the proportion of participants who met the Assessment of Spondyloarthritis International Society response criteria (ASAS40) after 16 or 52 weeks (one year) of treatment. ASAS40 is defined as an improvement of at least 40% and an increase of at least 10 units (on a scale of 0 to 100) in at least three of four domains: patient global assessment, pain, function (Bath Ankylosing Spondylitis Functional Index), and inflammation.
Results showed that significantly more patients receiving Cosentyx (after the induction phase) met ASAS40 after 16 weeks compared to placebo (42.2% vs. 29.2%). Similar results were found after one year of treatment. Cosentyx also led to improvements in secondary outcomes, including mobility, pain, and health-related quality of life.
Safety findings were in line with previous reports. Three cases of serious infections and one of Crohn’s disease were found in participants treated with Cosentyx.