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Abbott withdraws briakinumab applications in USA, Europe

World News | January 17, 2011


Kevin Grogan

Abbott withdraws briakinumab applications in USA, Europe

Abbott Laboratories has pulled its filings for the investigational psoriasis treatment briakinumab on both sides of the Atlantic after regulators said they needed to see more data.

The company revealed in a filing to the US Securities and Exchange Commission that it has withdrawn a US biologics license application and European marketing authorisation application for briakinumab. The decision has been taken after Abbott received feedback from regulatory authorities "indicating the need for further analysis and the potential for additional studies".

The US major says that it plans to evaluate next steps for the anti-interleukins 12 and 23 monoclonal antibody, "including resubmission, at a later date". The news came as a bit of a surprise, seeing as how in October, Abbott presented positive data from four Phase III studies which revealed that a greater percentage of moderate to severe chronic plaque psoriasis patients treated with briakinumab, achieved 75% or better skin clearance rates than those treated with the tumour necrosis factor Enbrel (etanercept), methotrexate or placebo.

At the time, Eugene Sun, head of global pharmaceutical development at Abbott, noted that while anti-TNFs "are the cornerstone of biologic treatment for psoriasis, these data suggest that briakinumab may be evaluated as a potentially important alternative treatment option for some psoriasis patients". However it is not a first-in-class drug, and Johnson & Johnson's IL-12/23 inhibitor Stelara (ustekinumab) is already on the market.

Forecasts for peak sales of briakinumab in 2019 hovered around the $800 million barrier. However, analysts do not seem overly concerned about the setback given that Abbott continues to be strong in psoriasis, thanks to its blockbuster biologic Humira (adalimumab).

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