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Novartis' Cosentyx cleared for wider use in Europe

Approved for psoriatic arthritis and ankylosing spondylitis

Novartis's first-in-class interleukin-17 inhibitor has been approved for psoriatic arthritis (PsA) and ankylosing spondylitis (AS) in the EU, adding to its current use in psoriasis.

The new indications will lend further momentum to Cosentyx (secukinumab), which has already made impressive sales as a treatment for moderate-to-severe psoriasis since its first launch in February.

Taken together, PsA and AS affect around 5m people in Europe, a major increase on the target patient population for the drug as psoriasis affects around 3.7m with around 2.5m in the moderate-to-severe category.

Novartis has previously said the two diseases could represent a market at least as big as psoriasis for Cosentyx and will be crucial if it is to reach its peak sales target of $5bn a year.

At the moment the standard biologic treatment for PsA and AS is with tumour necrosis factor (TNF) inhibitors, but the diseases are both under-diagnosed and under-treated, according to Novartis.

Moreover, new therapies are desperately required because around 40% of those who start treatment with TNF blockers do not respond sufficiently to therapy.

In PsA and AS trials, Cosentyx has shown to reduce symptoms as early as weeks one to three, and sustain those benefits for two years. Up to 80% of AS patients treated with Cosentyx showed no progression in spinal damage as measured by X-ray over two years, according to the company, while in PsA that figure was 84%.

"The strong treatment benefits seen in our studies suggest that Cosentyx may give patients the chance to stop the disease from progressing, preventing living with pain and disability," said Novartis' R&D chief David Epstein.

Cosentyx "has the potential to become a new standard of care for these common but under-treated inflammatory conditions," he added.

Novartis also has a lead in the anti-Il-17 category compared to rivals, which include AstraZeneca (AZ) and Valeant with brodalumab and Eli Lilly with ixekizumab in late-stage clinical trials and not exected to reach the market until 2016.

AZ recently suffered a possible setback with its candidate after former partner Amgen handed back rights to the drug - saying it was concerned about its safety profile - but Cosentyx' early sales performance suggests little anxiety that those concerns extend to the class as a whole.

Article by
Phil Taylor

23rd November 2015

From: Regulatory



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