Novartis has become the first company to secure approval for an interleukin-17 (IL-17) inhibitor after the authorities in Japan cleared its Cosentyx for psoriasis and psoriatic arthritis.
The Japanese Ministry of Health, Labour and Welfare (MHLW) cleared Cosentyx (secukinumab) as a second-line therapy after non-biologic systemic treatment for psoriasis or psoriatic arthritis has failed.
The green light in Japan comes after an FDA panel backed approval of the drug in the US in October and it was granted a positive opinion in the EU the following month.
As a class, the IL-17 blockers have been much anticipated by psoriasis patients and the clinicians who care for them because they have shown very high rates of skin clearance in trials, suggesting they target the underlying disease process more closely than other biologics such as the TNF inhibitors.
In psoriasis clinical trials, 70% of patients achieved clear or almost clear skin within the first 16 weeks of treatment with Cosentyx, which was maintained in the majority of patients for up to one year. Meantime, in psoriatic arthritis studies more than half of all patients exhibited a 20% improvement in symptoms, which was significantly more than placebo.
Novartis has beaten its anti-IL-17 rivals to the approval stage, with AstraZeneca (AZ) and Amgen’s brodalumab and Eli Lilly’s ixekizumab now competing for second place.
The drug will compete in the market most closely with Stelara (ustekinumab) from Johnson & Johnson (J&J), an IL-12 and IL-23 inhibitor that has also been making headway in the psoriasis market with sales of $1.5bn in the first nine months of 2014. Cosentyx outperformed Stelara in a head-to-head trial reported last month.
Analysts at Kepler Chevreux previously indicated they expect Cosentyx to achieve peak sales of around $700m in 2020, although others are more optimistic and say it could breach the $1bn-a-year barrier in that year.
The drug is also in clinical development for ankylosing spondylitis (AS), with filings due during 2015.