Novartis plans head-to-head trial for Cosentyx and Humira

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Novartis and Sandoz are to present new analyses indicating that their biologic Cosentyx could lead to higher responses than AbbVie’s anti-inflammatory super-blockbuster Humira in improving the signs and symptoms of ankylosing spondylitis and psoriatic arthritis.

The analyses are from two studies using the Matching-Adjusted Indirect Comparisons (MAIC), which the firms note is “a valid and accepted method for comparative effectiveness research”.

Novartis will now initiate new studies in patients with AS and PsA to directly compare Cosentyx (secukinumab) to Humira, marking “the first ever adequately powered long-term head-to-head studies with biologic medicines to differentiate the effectiveness of treatment in these conditions.”

“There is an urgent need for new ankylosing spondylitis and psoriatic arthritis treatments because a significant number of patients do not respond well to anti-TNF therapy, the current standard of care,” noted Vasant Narasimhan, Novartis chief medical officer and global head of drug development.

“There is a growing body of evidence that supports the potential of Cosentyx to become a gold standard of care for patients living with these debilitating conditions.”

In January last year, Cosentyx became the first fully human interleukin-17A inhibitor cleared to treat adults with moderate-to-severe plaque psoriasis, shortly after a green light was issued for psoriatic arthritis and ankylosing spondylitis in both the EU and US.

Novartis has previously published trial results showing that its drug was superior to Johnson & Johnson’s Stelara in clearing skin in psoriasis patients (PASI 90), was well as data from the Phase III FIXTURE study demonstrating its superiority Amgen’s Enbrel (etanercept). Pharmatimes.

10/06/2016 – Categoria: Farmaci – Da: Sh@wn – 378 letture





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