Abbott reported in a filing with the US Securities and Exchange Commission that it withdrew applications in the US and EU for its experimental psoriasis drug briakinumab. “Following feedback from regulatory authorities indicating the need for further analysis and the potential for additional studies, the company plans to evaluate next steps for briakinumab, including resubmission at a later date,” the drugmaker noted.
In its filing, Abbott wrote: “Following feedback from regulatory authorities indicating the need for further analysis and the potential for additional studies, the company plans to evaluate next steps for briakinumab, including resubmission at a later date.” This suggests the FDA and its European counterpart want to see more evidence on the safety side of the equation for briakinumab. Fortunately, several studies of briakinumab are ongoing.
At the J.P. Morgan healthcare conference, Abbott CFO Thomas Freyman commented that while the investigational anti-IL-12/23 monoclonal antibody was a “decent product,” it may have “niche” market potential and that Humira (adalimumab) was likely the better option for the treatment of psoriasis.
Credit Suisse recently estimated that briakinumab had sales potential of $456 million in 2015, whereas for the same year Humira has projected revenue of $8.1 billion.
