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Novartis to present inflammatory data

pharmafile | November 10, 2014 | News story | Business Services AS, Novartis, PSA, Secukinumab, acr 

Novartis is to present data from four pivotal Phase III trials in two debilitating inflammatory diseases at the American College of Rheumatology (ACR) Congress, which begins on Friday in Boston.

The company is making available abstracts on the progress of AIN457 (secukinumab) in psoriatic arthritis (PsA) and ankylosing spondylitis (AS) at ACR, which runs from 14-19 November.

Global regulatory applications of the investigative human anti-Interleukin-17A monoclonal antibody, will be made next year in both therapy areas, which have high unmet need and can lead to irreversible joint damage in patients.

The ACR abstracts include data from FUTURE 1 and FUTURE 2 in PsA and MEASURE 1 and MEASURE 2 in patients AS – all of which met their primary endpoints.

“Many patients have an inadequate or no response to available treatments,” says Vasant Narasimhan, global head of development at Novartis Pharmaceuticals. “We’re excited about the Phase III data we’re presenting at ACR 2014 and what these results could mean for patients.”

Secukinumab is the first selective IL-17A inhibitor with positive results in PsA and AS, which are common conditions of the spondyloarthritis (SpA) family of diseases.

The reason this may be significant is that IL-17A plays a key role in mobilising the body’s immune response in psoriasis and certain inflammatory arthritic diseases, such as PsA and AS.

Secukinumab has already been filed with regulatory authorities worldwide in moderate-to-severe plaque psoriasis, and Novartis anticipates approvals by the end of this year or early in 2015.

Novartis says that many people with PsA do not respond to or tolerate the current standard of care, anti-TNF (tumor-necrosis-factor) medicines, while there are few options available to people with AS.

If patients do not respond to non-steroidal anti-inflammatory drugs (NSAIDs), anti-TNF medicines are the only currently available biologic treatment – but these do not work for everyone.

Adam Hill

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