Novartis ($NVS) is well on its way to leading a new class of anti-inflammatory treatments, convincing European regulators to recommend approving its injected therapy for psoriasis and putting the company in line for transatlantic launches next year.
The European Medicines Agency is putting its weight behind secukinumab, an injected antibody that blocks the an inflammation-related protein called interleukin-17. The recommendation is based on pivotal data in which Novartis' drug significantly reduced the symptoms of psoriasis--and proved superior to Amgen's ($AMGN) blockbuster Enbrel--and full approval usually follows within about three months.
The treatment, to be marketed as Cosentyx, is on its way toward a likely FDA approval, as well, winning a unanimous recommendation from an agency panel last month and expecting final word in January. Assuming 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 are injected therapies that inhibit tumor necrosis factor (TNF), including Enbrel and AbbVie's ($ABBV) top-selling Humira. But Novartis believes its contender can disrupt the market, pointing to a National Psoriasis Foundation survey in which 52% of patients surveyed said they were dissatisfied with their disease management.
But while Novartis will likely be first to the IL-17 market, it's soon to be joined by a slew of other anti-inflammatory biologics targeting the same multibillion-dollar space. Behind secukinumab is Amgen and AstraZeneca's ($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.
Psoriasis is Novartis' first priority with secukinumab, followed by psoriatic arthritis, in which it notched impressive Phase III results in September. Beyond its top two targets, 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 Novartis' statement
- here's the EMA's release (PDF)