Novartis' ($NVS) new anti-inflammatory treatment cleared up psoriasis better than Johnson & Johnson's ($JNJ) Stelara in a Phase III trial, a second head-to-head victory for the injectable drug as it nears U.S. and European approvals.
In a 679-patient study, Novartis' secukinumab met its primary goal of reducing psoriasis symptoms by at least 90% at 16 weeks, the company said, demonstrating superiority to J&J's treatment. The antibody also met its secondary endpoint of improving the signs of psoriasis by at least 75% after four weeks, according to Novartis.
Stelara, which brought in $1.5 billion for J&J last year, is the latest victim of Novartis' ambitious clinical program for secukinumab. The treatment, which blocks an inflammation-related protein called interleukin-17, beat out Amgen's ($AMGN) roughly $9-billion-a-year Enbrel in a Phase III study earlier this year.
The treatment, to be marketed as Cosentyx, is on its way toward a likely FDA approval, winning a unanimous recommendation from an agency panel in October and expecting final word in January. The European Medicines Agency has also signed off on secukinumab's promise, handing down a recommendation for approval last month and setting the stage for a 2015 continental launch. If all goes according to plan, Novartis' injection will be the first IL-17 blocker to hit the market, leading a pack of new treatments that could improve the standard of care for psoriasis, psoriatic arthritis and other inflammatory diseases.
As it stands, the most common option for psoriasis sufferers is injected therapies that inhibit tumor necrosis factor (TNF), including Enbrel and AbbVie's ($ABBV) top-selling Humira. But Novartis believes its contender can disrupt the market, pointing to a National Psoriasis Foundation survey in which 52% of patients surveyed said they were dissatisfied with their disease management.
|Novartis Head of Development Vasant Narasimhan|
"We are delighted that our IL-17A inhibitor Cosentyx showed superiority over Stelara, a widely used biologic for moderate-to-severe psoriasis patients and a newer treatment alternative to TNF inhibitors," Novartis Head of Development Vasant Narasimhan said in a statement. "Patients need more effective treatment options for psoriasis and these impressive results add to the robust body of evidence that patients dramatically benefit and can achieve clear skin with Cosentyx."
But while Novartis will likely be first to the IL-17 market, it's soon to be joined by a slew of other anti-inflammatory biologics targeting the same multibillion-dollar space. Behind secukinumab is Amgen and AstraZeneca's ($AZN) brodalumab, a similar treatment that beat Stelara in a Phase III study of its own. Meanwhile, Eli Lilly ($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 IL-23 inhibitor guselkumab, which is set to enter Phase III this quarter.
- read the results