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Novartis’ Cosentyx scores again in phase 3, strengthens approval claim

Scopes approval in non-radiographic axial spondyloarthritis


Novartis has unveiled more positive phase 3 data for Cosentyx, this time in patients with non-radiographic axial spondyloarthritis (nr-axSpA). 

The Swiss drugmaker has strengthened Consentyx’s (secukinumab) claim as class leader as it preps for a new filing in nr-axSpA.

The positive data comes from the phase 3 PREVENT trial, which aimed to measure the number of patients achieving an ASAS40 response, which is characterised by at least 40% improvement in patient global assessment, pain, function and inflammation.

It met this primary endpoint, with responses at week 52 demonstrating that Consentyx showed a significant reduction in disease activity for nr-axSpA patients compared to placebo.

According to Novartis, the previous positive data from week 16 of the trial were submitted to EMA to support approval of Consentyx in September. This adds to the five years of clinical data supporting the efficacy of the drug in ankylosing spondylitis, psoriatic arthritis and psoriasis.

The interleukin-17 inhibitor is already approved for another form of the disease, ankylosing spondylitis, but this new data shows sustained benefit in a more tricky form of the condition – nr-axSpA is not visible on x-ray, the standard diagnostic tool for joint damage.

Both conditions on the spectrum carry similar symptoms, and if left untreated can impair activity and have a significant impact on quality of life.

“These data are encouraging for people living with nr-axSpA, where there are only limited treatment options available,” said John Tsai (pictured below), head of global drug development and chief medical officer of Novartis.


John Tsai

“It’s a great example of how we’re working to reimagine medicine to help patients realise early relief from this disease,” he added.

Novartis may have been first-to-market with Cosentyx, but it is still facing increasing competition, namely from Eli Lilly’s Taltz (ixekizumab). The rival IL-17 inhibitor won approval in ankylosing spondylitis in August, meaning it now has the same diseases on its label as Cosentyx.

However, if Cosentyx can win approval in nr-axSpA – which Taltz also has positive date for – it could continue its lead and bring in more sales growth for Novartis. Cosenytx grew by almost a third to $1.65bn in the first half of the year, becoming Novartis’ top-selling product. Taltz has also been growing at speed, with first-half sales rising 65% to $606m.

Article by
Lucy Parsons

3rd October 2019

From: Research



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