|Novartis' Vasant Narashimhan|
Just days after an FDA advisory group gave its unanimous blessing to Novartis for secukinumab (AIN457) as a new treatment for plaque psoriasis, the pharma giant has produced a new slate of Phase III data backing the IL-17 therapy for ankylosing spondylitis.
Novartis ($NVS) stuck with topline results for the announcement today, saying that secukinumab hit primary endpoints for "signs and symptoms of the disease (AS) versus placebo and associated improvements in physical function and quality of life."
Novartis has long believed that secukinumab represents one of its best late-stage efforts. And it's wasting no time in targeting a lineup of global approvals to drive a marketing campaign for several conditions. In addition to its near-term prospects for an approval on plaque psoriasis, which could land before the end of this year, Novartis says that it's marching straight to new applications in 2015 for AS as well as psoriatic arthritis.
The antibody has proven an effective blocker of IL-17, an inflammatory protein that plays havoc in the human body. Patients currently rely on anti-tumor necrosis factor (TNF) drugs like Enbrel, a megablockbuster that is likely to be cut down to size by a new generation of drugs. And Novartis is playing in a very competitive field. Behind secukinumab is Amgen ($AMGN) and AstraZeneca's ($AZN) brodalumab, a similar treatment that has notched impressive Phase III results in psoriasis and psoriatic arthritis. Meanwhile, Eli Lilly ($LLY) is in the midst of Phase III with the IL-17-blocking ixekizumab, trailed by Merck's ($MRK) MK-3222 and Johnson & Johnson's ($JNJ) IL-23 inhibitor guselkumab, which is set to enter Phase III this quarter.
"We are thrilled to see positive results with secukinumab in AS, a gravely debilitating condition with a significant remaining unmet need as up to 40% of patients do not respond to anti-TNF therapies," said Vasant Narasimhan, global head of development, Novartis Pharmaceuticals. "With these results in AS and the recently announced positive results in psoriatic arthritis, we now have data from four Phase III trials of secukinumab in spondyloarthropathies which we look forward to presenting at a congress later this year."
- here's the release