Novartis' arthritis drug to take on Stelara

New Phase 3 data from Novartis' secukinumab shows the drug is effective in treating psoriatic arthritis (PsA).

The company says it will use the new data in its submission to regulators in 2015. The drug is not yet on the market – its first filing, for moderate-to-severe plaque psoriasis, is expected to gain approval later this year or in early 2015.

Novartis' drug is in the interleukin antagonist class, closely related to Janssen's existing treatment Stelara (ustekinumab), which has been a huge success in the field since its launch in 2013.

Secukinumab blocks interleukin-17A (IL-17A) a protein that is central to the development of inflammatory diseases, whereas Stelara targets IL-12/23. Janssen's drug is on course to earn sales of $2 billion this year, and is the drug to beat in the therapy area.

Novartis will also be competing with another new therapy in the field, Celgene's Otezla, which gained US approval in March.

Head-to-head studies

Novartis is convinced of the drug's superiority to its rivals in psoriasis, and has already conducted a head-to-head with Amgen/Pfizer's Enbrel in a study called FIXTURE. This showed that secukinumab was significantly superior to Enbrel in clearing skin.

In March this year, the company announced it was commencing a 52-week, head-to-head with Stelara in psoriasis, which it hopes will also yield a win for its new entrant.

The strength of these results is likely to influence practice in PsA, but it is not clear if Novartis will launch head-to-head trials in this indication as well.

Many people with PsA do not respond to current standard of care, with Novartis citing research which suggest that around 45% of people are dissatisfied with their current treatments.
The disease is a debilitating, long-lasting condition that causes inflammation of joints and skin, and affects up to 30% of people with psoriasis around the world. Methotrexate is the current standard first line therapy in most developed countries, with some patients then moving on to TNF-a blockers such as Enbrel.

"Building on the positive data previously reported in psoriasis, we are excited to present the first Phase III results of secukinumab in PsA. These positive results are planned to form the basis of a filing application to regulatory authorities in this indication," said Vasant Narasimhan, global head of Development, Novartis Pharmaceuticals.

"Effective new therapies are urgently needed for newly PsA diagnosed patients and for nearly half of PsA patients who are dissatisfied with or not responding to their current treatments."

Secukinumab is also in clinical trials for the treatment of ankylosing spondylitis (AS) and rheumatoid arthritis (RA).