This article is more than 5 years old. Information may no longer be current.
EMA supports Humira for moderate-to-severe Crohn’s disease in children
Click Here to Manage Email Alerts
The European Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion for Humira for treating moderately to severely active Crohn’s disease in children aged 6 years and older with inadequate response to conventional therapies, according to a press release from the manufacturer.
Humira (adalimumab, AbbVie) is approved in the European Union for severe active Crohn’s disease in children with inadequate response or inability to receive conventional treatments including primary nutrition therapy, corticosteroids and immunomodulators.
“The positive CHMP opinion represents a significant milestone for the pediatric gastroenterology community as we move closer to European approval of Humira in pediatric patients with moderately to severely active Crohn’s disease, a chronic condition with no known cure that affects a growing number of children worldwide,” Michael Severino, MD, executive vice president of research and development and chief scientific officer of AbbVie, said in the press release. “AbbVie is committed to the ongoing study and innovation of Humira, and we look forward to expanding this treatment option, once approved, to help more children with this debilitating illness during a vulnerable time in their lives.”
The EMA’s positive opinion follows results from the IMAgINE-1 study, a large multicenter, randomized, open-label induction trial, followed by a double blind maintenance trial in children aged 6 to 17 years with moderately to severely active Crohn’s disease. In the 4-week induction period, 80 mg and 40 mg was administered subcutaneously at weeks 0 and 2, respectively, for patients who weighed less than 40 kg, and 160 mg and 80 mg, respectively, for patients who weighed greater than 40 kg. After induction, 188 patients were randomly assigned to receive a standard dose (20 mg or 40 mg every other week depending on weight) or low-dose (10 mg or 20 mg every other week depending on weight).
At week 26, 63 patients (33.5%) achieved clinical remission, defined using the Pediatric Crohn’s Disease Activity Index. Moreover, a larger proportion of patients who received a standard-dose achieved clinical remission compared with those who received a low-dose at week 26 (36 of 93 vs. 27 of 95 patients; P=0.075) and at week 52 (31 of 93 vs. 22 of 95 patients; P = 0.1)
“A large-scale investigation such as the IMAgINE trial showcases the safety and efficacy profile of Humira in the moderately to severely active pediatric Crohn’s disease population,” Jeffrey S. Hyams, MD, head of the division of digestive diseases, hepatology and nutrition at Connecticut Children’s Medical Center, said in the press release.
The variation to the Marketing Authorization is being reviewed under the centralized licensing procedure, and if approved, the authorization will be valid in all 28 member states of the European Union, and also in Iceland, Liechtenstein and Norway, according to the press release.
Disclosure: Severino is employed by AbbVie. Healio Gastroenterology was unable to confirm Hyams’ relevant financial disclosure at the time of publication.