Novartis' psoriasis drug looks good enough to approve, FDA staff says

The benefits of Novartis' ($NVS) new anti-inflammatory treatment outweigh its risks, according to FDA reviewers, an opinion that improves the odds of approval for a drug the company hopes can bring in blockbuster sales.

The treatment, secukinumab, is an injected antibody that blocks interleukin-17, a protein that plays a major role in inflammation. In documents released ahead of panel meeting, FDA staff heralded its effects on psoriasis, noting that, across a 3,300-patient Phase III program, secukinumab significantly reduced symptoms of the skin ailment while charting an adverse event profile in line with placebo.

Next week, a panel of FDA advisers will weigh in on the treatment, voting whether to recommend it for full approval. The agency is due to hand down a final decision on secukinumab by January.

If, as expected, Novartis' drug wins approval, the company will be the first to market with an IL-17 therapy, leading a class of promising treatments that could improve the standard of care for psoriasis, psoriatic arthritis and other inflammatory diseases. In an earlier Phase III trial, secukinumab beat out Amgen's ($AMGN) Enbrel, an anti-TNF drug that brought in about $8.8 billion last year, highlighting its potential to be an immediate disrupter on the market.

But any IL-17 exclusivity will likely be short-lived, as a cadre of rivals are gearing up for regulatory submissions in 2015. Behind secukinumab is Amgen and AstraZeneca's ($AZN) brodalumab, a similar treatment that has notched impressive Phase IIII results in psoriasis and psoriatic arthritis. Meanwhile, Eli Lilly ($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) guselkumab.

Novartis has psoriatic arthritis ambitions of its own, last month unveiling results from two Phase III trials in which secukinumab relieved symptoms, prevented joint damage and helped maintain clear skin.

Beyond its top two indications, secukinumab is also in development for ankylosing spondylitis and rheumatoid arthritis, with filings for those conditions expected next year. If Novartis 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 briefing (PDF)

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