Novartis AG NVS announced the full-52 week data from the ongoing PREVENT study on spondylitis drug, Cosentyx (secukinumab). The new, detailed data from the study reinforced the drug’s substantial and sustained benefits across axial spondyloarthritis (axSpA) spectrum.
Data from the study showed that treatment with 150mg dose of Cosentyx achieved significant and sustained improvements in signs and symptoms of non-radiographic axial spondyloarthritis (nr-axSpA) at 52 weeks. Treatment with Cosentyx improved signs and symptoms of nr-axSpA in patients by 40% as measured by Assessment of Spondyloarthritis International Society score, compared to placebo at week 16 and week 52. The company had announced late last year that the drug met the primary endpoint of the PREVENT study.
PREVENT is an ongoing two-year randomized, double-blind, placebo-controlled phase III study (with a two-year extension phase) investigating the efficacy and safety of Cosentyx in patients with active nr-axSpA.
Notably, axial spondyloarthritis (axSpA) is a spectrum of long-term inflammatory disease characterized by chronic inflammatory back pain. nr-axSpA forms part of the axSpA spectrum and is characterized by chronic inflammatory back pain and symptoms such as nocturnal pain, morning stiffness and impaired quality of life. The spectrum includes ankylosing spondylitis (AS), in which joint damage is visible on x-ray, and nr-axSpA, in which joint damage is not visible on x-ray.
Per estimates, approximately 1.7 million patients with nr-axSpA are living in the European Union and the United States.
Please note that Cosentyx was approved in Europe as a treatment for nr-axSpA in April. Novartis has also submitted a regulatory application to the FDA seeking approval for the drug in the same indication. Data from the PREVENT study can support a potential approval. Launch of the drug in the U.S. and European markets will likely boost its sales on the back of a significant patient population.
However, there are several other drugs available for treating axSpA including Lilly’s LLY Taltz, which received approval for a label expansion to include nr-axSpA patients earlier this week.
Novartis’ shares have lost 1.7% in the year so far compared with the industry’s decline of 2.8%.
Cosentyx is the first and only fully-human biologic that directly inhibits interleukin-17A (IL-17A). The drug is already approved for treating plaque psoriasis, psoriatic arthritis and ankylosing spondylitis. Sales of the drug came in at $930 million in the first quarter of 2020, representing a year over year growth of 19%.
However, the drug faces stiff competition from the likes of Johnson & Johnson's JNJ Stelara and Tremfya, and AbbVie’s ABBV Skyrizi in various indications.
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Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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