Abbott’s Humira gets priority review in Crohn’s

Drugs granted priority status can be reviewed in six months, rather than the standard ten. Abbot said that the FDA based its decision on the results of a recent 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 (GI) track that may affect more than one million people in North America and Europe. There is no medical or surgical cure for Crohn’s disease and few options for patients suffering with this chronic condition.

“Patients who have failed infliximab have limited treatment options and this decision underscores the need for new therapies that address unmet medical needs,” said Eugene Sun, vice president of global pharmaceutical clinical development at Abbott. “We are pleased the FDA has granted priority review to Humira for the treatment of Crohn’s disease.”