Abbott's Humira granted priority review for CD

US health care major Abbott Laboratories says that the Food and Drug Administration has granted a priority review for its recent supplemental Biologics License Application for Humira (adalimumab) as a treatment for moderately to severely active Crohn's disease. The sBLA was based on findings released earlier this month from the GAIN study, which showed the agent induced clinical remission at four weeks in CD patients who lost response to, or were intolerant to, infliximab therapy.

The FDA's priority status indicates Humira's potential to address an unmet medical need for CD, says Abbott. The goal for reviewing such a drug is six months versus a standard 10-month review.