Novartis ($NVS) has picked up FDA and European approvals to sell its secukinumab as a treatment for psoriasis, the first steps in the company's plot to build a global anti-inflammatory contender and outpace its rivals.
The injected treatment, to be marketed as Cosentyx, blocks an inflammation-related signaling protein called interleukin-17 to beat back the itchy, flaky scales that characterize psoriasis. In its sweeping Phase III program, Novartis' antibody significantly improved skin clarity compared to placebo and proved superior to Johnson & Johnson's ($JNJ) Stelara and Amgen's ($AMGN) Enbrel, two blockbuster therapies.
The FDA's decision, handed down Wednesday, comes two days after European authorities gave the treatment a green light. And, with its global launch to come, secukinumab becomes the first IL-17 inhibitor cleared for psoriasis, beating out Amgen and AstraZeneca's ($AZN) brodalumab and Eli Lilly's ($LLY) ixekizumab among treatments expected to change the standard of care for the disease.
As it stands, the most common options for psoriasis sufferers are injected therapies that inhibit tumor necrosis factor (TNF), including Enbrel and AbbVie's ($ABBV) top-selling Humira. But Novartis believes IL-17 blockers 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. And secukinumab's victories over Stelara, a $1.5 billion drug, and Enbrel, which brings in $9 billion a year, suggest a sizable market opportunity.
Now Novartis is at work expanding the potential indications for secukinumab, running late-stage programs in psoriatic arthritis, ankylosing spondylitis and rheumatoid arthritis with plans for follow-on filings this year. If everything goes according to plan, analysts say the treatment could bring in $1 billion in annual sales by 2020.
"The FDA's approval of Cosentyx signifies a turning point for psoriasis patients, who can now benefit from the first and only approved treatment targeting the IL-17 pathway, which is proven to play a key role in the development of plaque psoriasis," Novartis pharma chief David Epstein said in a statement. "This important milestone will now allow patients to receive a treatment that has the proven ability to offer clear or almost clear skin."
But Novartis' rivals are close on its heels. Amgen and AstraZeneca expect to file brodalumab this year, and Lilly is on a similar timeline with ixekizumab. Meanwhile, Merck ($MRK) is working through Phase III with the IL-23-blocking tildrakizumab, and J&J has begun late-stage testing on its similar guselkumab.
- read the FDA's release
- here's Novartis' statement on the European nod