Novartis hails ‘groundbreaking’ results in ankylosing spondylitis

A new treatment for the debilitating spinal condition ankylosing spondylitis (AS) could help many patients for whom standard anti-TNF drugs don’t work.

Vasant Narasimhan, Global Head of Development at Novartis hailed the phase 3 results of secukinumab in patients with the condition as ‘groundbreaking’ however the firm faces intense competition from other new biologics in the rheumatology and inflammation field.

Up to 40% of people treated for AS have inadequate or no response to anti-TNF drugs such as AbbVie’s Humira and Janssen’s Remicade, and Novartis’s new drug secukinumab looks very promising in these patients.

Results from the MEASURE 1 phase 3 trial of secukinumab found more than 60% of secukinumab 150 mg patients achieved significant improvements in AS symptoms, seen as early as Week 1 and sustained through one year of treatment.

Secukinumab (AIN457) is a human monoclonal antibody that selectively neutralises IL-17A[12]. The drug is the first in its class to show positive phase 3 results in AS. Research shows IL-17A plays an important role in driving the body’s immune response in psoriasis and other inflammatory arthritic diseases, including AS.

Novartis also has the drug in trials for the treatment of psoriatic arthritis (PsA) and rheumatoid arthritis (RA). Global regulatory applications for secukinumab in AS and PsA are planned for 2015.

This follows the secukinumab global regulatory applications for moderate-to-severe plaque psoriasis which were filed in October 2013 with approvals anticipated in late 2014 or early 2015. Novartis is just one step away from this first approval, with an FDA committee voting unanimously on 20 October to recommend the drug for this use.

Analysts are cautious about the drug’s sales forecasts, as the competition in the field is intense. Secukinumab has a very strong rival in the IL-17 class, Amgen and AstraZeneca’s brodalumab. The molecule has just won out in a head-to-head trial against Janssen’s anti-IL12/23 Stelara in a phase 3 trial in plaque psoriasis, giving it an ace card coming onto the market.

Another contender is Lilly’s ixekizumab, which recently produced its own winning results in a phase 3 head-to head with Pfizer’s Enbrel (etanercept) and placebo in plaque psoriasis.

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