A panel of FDA advisers voted unanimously in favor of approving Novartis' ($NVS) new anti-inflammatory treatment, an expected positive outcome for the company as it races to be first in line among what promises to be a crowded field.
Novartis' treatment, secukinumab, is an injected antibody that blocks interleukin-17, a protein that plays a major role in inflammation. The FDA's Dermatologic and Ophthalmic Drugs Advisory Committee voted 7-0 that the company's pivotal data support the approval of secukinumab to treat plaque psoriasis, the first of Novartis' desired indications.
The FDA isn't beholden to follow the whims of its advisers, though it commonly does, and the agency is due to hand down a final decision on secukinumab's future in psoriasis in January.
If Novartis' drug wins approval, it'll be the first IL-17 blocker to hit the market, leading a pack of new treatments that could improve the standard of care for psoriasis, psoriatic arthritis and other inflammatory diseases.
Currently, the most common option for psoriasis sufferers are injected therapies that inhibit tumor necrosis factor (TNF), treatments that have brought in blockbuster sales. But Novartis believes its contender can disrupt the market, pointing to a National Psoriasis Foundation survey in which 52% of patients surveyed said they were dissatisfied with their disease management. And the company has plenty of data to back up its case for secukinumab, including results from a Phase III psoriasis trial in which the treatment beat out Amgen's ($AMGN) Enbrel, an anti-TNF drug that brought in about $8.8 billion last year.
|Novartis' Vas Narashimhan|
"We are pleased with today's unanimous recommendation, which is based on the efficacy and safety data put forth in our robust clinical trial program, and the advisory committee decision brings us one step closer to delivering an innovative, new treatment option for people suffering from moderate-to-severe psoriasis," Novartis Global Head of Development Vas Narasimhan said in a statement. "There is a need for novel therapies, as not all treatments are appropriate or effective in every patient."
But while Novartis will likely be first to the IL-17 market, it's soon to be joined by a slew of other anti-inflammatory biologics targeting the same multibillion-dollar space. Behind secukinumab is Amgen and AstraZeneca's ($AZN) brodalumab, a similar treatment that 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.
Novartis has psoriatic arthritis ambitions of its own, last month unveiling results from two Phase III trials in which secukinumab relieved symptoms of that disease, preventing joint damage and helping to maintain clear skin. Beyond the two leading indications, secukinumab is also in development for ankylosing spondylitis and rheumatoid arthritis, with filings for those conditions expected next year.
If the company can pull off all four approvals for its antibody, analysts have speculated that the drug could clear $1 billion in annual sales by 2020.
- read the announcement (PDF)