According to a press release on Global Newswire, Novartis has received a positive opinion on Cosentyx® from the Committee for Medicinal Products for Human Use (CHMP). This positive opinion is in relation to the treatment of adult patients with non-radiographic axial spondyloarthritis (nr-axSpA). Read the full press release here.
About Non-Radiographic Axial Spondyloarthritis
Non-radiographic axial spondyloarthritis (nr-axSpA) is a condition which causes inflammation in the body, particularly in the spine. However, joints can also be affected. According to a summary of the disorder published in the Israel Medical Association Journal, patients with nr-axSpA experience symptoms such as back pain and stiffness, loss of mobility, and fatigue.
While patients with similar diseases like ankylosing spondylitis may have symptoms or damage appearing on an X-ray or CT scan, those with nr-axSpA do not, hence the term “non-radiographic.”
Both nr-axSpA and ankylosing spondylitis (AS) belong to a group of diseases called spondyloarthropathies. Unlike non-radiographic axial spondyloarthritis, damage from AS does show up on scans. AS occurs when vertebrae in the back fuse together, and the spine becomes inflamed. Inflammation from AS can also spread to the hips, shoulders, and knees. In 40% of patients, inflammation of the eyes also occurs. Learn more about AS on our website.
About Novartis Cosentyx®
According to their website, Novartis is a global medicine company comprised of two branches: Novartis Pharmaceuticals and Novartis Oncology. In their pharmaceutical branch, Novartis seeks innovative and effective therapies to treat patients who may lack options for their specific conditions.
Cosentyx® is a fully-human biologic designed to prevent the development of Interleukin-17A, also known as IL-17A. This protein is secreted by the immune system. However, in patients with non-radiographic axial spondyloarthritis, this protein is one of the causes of inflammation. IL-17A also causes inflammation in patients with ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
A positive opinion means that the CHMP advocates for the authorization and use of a particular medicine or therapy. Before receiving a positive opinion, Novartis has five years of data on Cosentyx® in treatment for ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. Over 300,000 patients have been treated with Cosentyx® since it was first released. Clinical data shows that Cosentyx® is both effective and safe for long-term use.
Positive CHMP Opinion
The CHMP granted the most recent positive opinion following the PREVENT Phase III study. This study followed 555 patients with non-radiographic axial spondyloarthritis. Many had symptoms that did not respond to use of NSAIDs. Compared to patients using a placebo, patients using Cosentyx® showed marked improvement of 40% in symptoms and response criteria.
Novartis’ Eric Hughes stated:
“Non-radiographic axial spondyloarthritis…is a painful and debilitating disease for which there are limited treatment options available. This positive opinion marks another step forward in our commitment to…help patients realize relief.”
About 1.7 million patients between the United States and the top five European countries (France, Germany, Italy, UK, Spain) have nr-axSpA. If approved, Cosentyx® will be the first IL-17A inhibitor for European patients.