Novartis plans FDA approval as it hits endpoint for Consentyx in axial spondyloarthritis
pharmafile | October 3, 2019 | News story | Research and Development |
Novartis has announced positive data from its PREVENT trial, which evaluated the safety and efficacy of Cosentyx (secukinumab) for patients with non-radiographic axial spondyloarthritis, ultimately showing a clinically meaningful reduction in disease activity versus placebo.
The ongoing Phase 3 trial met it primary endpoint at Week 52 and demonstrated a sustained response and a safety profile that was consistent with previous clinical trials.
Novartis had already announced positive 16-week PREVENT data and submitted Cosentyx for approval to the European Medicines Agency.
John Tsai, Head of Global Drug Development and Chief Medical Officer for Novartis, said: “These data are encouraging for people living with non-radiograhpic axial spondyloarthritis, where there are only limited treatment options available.
“It’s a great example of how we’re working to reimagine medicine to help patients realise early relief from this disease.”
Atul Deodhar, professor of medicine and Medical Director of Rheumatology Clinics at Oregon Health and Science University, added: “Non-radiographic spondyloarthirtis is a chronic debilitating disease, which left untreated can have a significant impact on patients’ quality of life.
“These positive results indicate a new potential new treatment option to help patients experience relief from the signs and symptoms of their disease.”
Cosentyx which is currently approved for numerous other conditions generated sales of $858 million in the second quarter, representing a 22% year-on-year growth rate.
Competition may now be heating up as Eli Lilly also announced that Taltz (ixekizuamb) met the primary and all major secondary endpoints in the late-stage COAST-X trial evaluating the IL-17A inhibitor in non-radiographic axial spondyloarhrtiis for patients not previously treated with biologic disease-modifying anti-rheumatic drugs.
Nik Kiran
