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Novartis gains label boost for Cosentyx

Updated label allows dosing flexibility of up to 300mg


Novartis' inflammation therapy blockbuster Cosentyx has added a new dosing flexibility in Europe for psoriatic arthritis patients.

A label update has been authorised by the European Commission today, boosting the drug's leading status in a crowded field of competitiors. The drug is one Novartis's brightest performers currently, earning more than $2bn in the first nine months of 2018, and nearly doubling sales in Q3.

Cosentyx has been in the psoriatic arthritis (PsA) market for almost four years now, and has also established itself in plaque psoriasis and ankylosing spondylitis.

Thmaintenance update allows a dosing flexibility of up to 300mg for patients with psoriatic arthritis, a higher dose which could help bring the disease under control.

The boost was based on 24-week structural disease progression data from FUTURE 5, which became the largest phase 3 study for a biologic conducted in PsA to date.

In the study, which included a subcutaneous regimen, the medicine demonstrated that Cosentyx inhibits progression of joint damage in PsA, with almost 90% of patients treated with Cosentyx at 300mg had no radiographic disease progression at 24 weeks.

"Cosentyx is the only IL-17A inhibitor to demonstrate 5-year safety and efficacy in phase 3 studies of PsA and AS. We are reimagining the well-being of patients living with all facets of psoriatic arthritis," said Eric Hughes, Global Development Unit Head, Immunology, Hepatology and Dermatology.

"This label update further supports prescribing doctors and patients in their treatment choice."

The maintenance update could help boost Cosentyx’s position in the psoriatic arthritis market, which is expected to swell up to $12.6bn by 2025, from $4.3bn three years ago.

The lack of long-term efficacy for psoriatic arthritis treatments causes patients to move onto other options to keep on top of the condition.

Other IL-17 inhibitors include Lilly’s Taltz and AstraZeneca’s Lumicef, plus Celgene’s oral therapy Otezla are all battling for market share drive.

Article by
Gemma Jones

26th October 2018

From: Regulatory



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