ABBOTT'S HUMIRA SBLA GRANTED PRIORITY REVIEW

Abbott announced that the FDA has granted priority review to its recent supplemental biologics license application (sBLA) for Humira (adalimumab) as a treatment for moderately to severely active Crohn's disease. The FDA's decision is based on findings released earlier this month from the GAIN study, which showed Humira induced clinical remission at four weeks in patients with moderately to severely active Crohn's disease who lost response to, or were intolerant to, infliximab therapy.

Crohn's disease is a serious, chronic inflammatory disease of the gastrointestinal track that may affect more than 1 million people in North America and Europe, according to Abbott. The FDA granted priority-review status to Humira based on its potential to address an unmet medical need. Additional FDA attention and resources are directed to drugs with priority-review status, but it does not alter the scientific/medical standard for approval or the quality of the evidence necessary, Abbott said.

GAIN, a randomized, double-blind, placebo-controlled study, was designed to assess the efficacy and safety of Humira in moderately to severely active Crohn's disease in patients who previously lost response to, or were intolerant to, infliximab therapy, a group currently without effective treatment options. Data from the study of 325 patients showed significantly higher rates of remission for patients receiving Humira compared with those receiving placebo at week four, 21 percent versus 7 percent, respectively.