Credit: S.Harris/NPG

EU regulators recommended approval for Novartis' secukinumab for first-line treatment of plaque psoriasis, ahead of an anticipated FDA approval.

The lowdown: Interleukin-17 (IL-17) was first identified in 1993, and the cytokine was quickly recognized to have a key role in many inflammatory and autoimmune diseases. Twenty-two years on, the first IL-17 inhibitor is set to hit the market. The European Medicines Agency has given the thumbs up to Novartis' secukinumab for plaque psoriasis, and a final approval from the European Commission will come through shortly. In clinical trials, the drug was significantly superior to Amgen's tumour-necrosis factor (TNF)-targeting etanercept at 12 weeks. In October, an independent US Food and Drug Administration advisory panel voted unanimously that the available data support an approval of secukinumab for plaque psoriasis in the United States as well.

The drug is in Phase III trials for psoriatic arthritis, ankylosing spondylitis and rheumatoid arthritis as well. Analysts expect the drug to hit blockbuster status by 2019, according to the Thomson Reuters Cortellis database.

Two other antibodies targeting the IL-17 pathway are in late-stage development: one against the IL-17 receptor (IL-17R) and the other against IL-17. Amgen and AstraZeneca's brodalumab, which targets IL-17R, is in Phase III trials for psoriasis and psoriatic arthritis. In November, the companies reported the third Phase III psoriasis success for the antibody, with two trials showing superiority over Johnson & Johnson's IL-12- and IL-23-targeting ustekinumab. Eli Lilly's ixekizumab is in Phase III trials for the same two indications. In August, the company presented the first Phase III psoriasis data from the drug, showing that it was superior to etanercept. The sponsors debate the merits of targeting the cytokine itself versus the receptor (Nature Rev. Drug Discov. 12, 815–816; 2013). Regulatory filings for each of the two antibodies are expected in the first half of 2015.

AbbVie's ABT-122 bispecific antibody, which targets IL-17 and TNF, is in Phase II development for rheumatoid arthritis.