The US Food and Drug Administration (FDA) has approved AbbVie's Humira (adalimumab) for reducing signs and symptoms, and achieving and maintaining clinical remission, in paediatric Crohn's disease patients 6 years of age and older when certain other treatments have not worked well enough. This FDA approval represents the eighth indication for Humira in the United States and makes it the first and only biologic treatment approved for use in this patient population that can be administered at home.
"Moderate to severe Crohn's disease is a serious chronic disorder that can impact children and adolescents in significant ways during this important stage of their lives," said Jeffrey S Hyams, M.D., head, Division of Digestive Diseases, Hepatology and Nutrition, Connecticut Children's Medical Center. "The approval of Humira for this patient population offers a new important treatment option for physicians and their patients that can help address this sometimes debilitating disease."
Crohn's disease is a type of inflammatory bowel disease (IBD) which commonly involves the end of the small intestine and the large intestine. Crohn's disease can appear at any age, but it is most often diagnosed in adolescents and young adults between 15 and 35 years of age. In the United States, there are an estimated 38,000 children and teens with Crohn's disease. Symptoms of paediatric Crohn's disease are similar to those in adults and can include abdominal pain, weight-loss and diarrhoea. Additionally, when Crohn's disease is diagnosed in childhood, it may be more extensive than when it is diagnosed in adulthood Since there is no known cure for Crohn's disease, one of the treatment goals of paediatric Crohn's disease is to induce and maintain clinical remission.
"Children living with moderate to severe Crohn's disease have limited treatment options and AbbVie is pleased that Humira will now be an available option for many of these patients," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This approval underscores our continued commitment to innovate with Humira, both in studying potential new indications to help meet unmet medical needs and in helping to improve the standard of care for patients living with immune-mediated inflammatory diseases like Crohn's disease."
Humira works by inhibiting tumour necrosis factor-alpha (TNF-a) and can be self-administered after proper injection training is received and with appropriate physician monitoring.
In 2012, the European Commission approved Humira for the treatment of paediatric patients 6 to 17 years of age with severe active Crohn's disease who failed, are intolerant to, or have contraindications to conventional therapy.
The FDA approval was supported by the phase 3 IMAgINE-1 trial, which evaluated multiple dosing strategies of Humira to induce and maintain clinical remission in paediatric patients with moderately to severely active Crohn's disease for whom certain other treatments have not worked well enough. IMAgINE-1 is the largest multi-centre, randomised, double-blind anti-TNF trial in patients 6 to 17 years of age with moderately to severely active Crohn's disease conducted to date.
Humira is a prescription medicine used to reduce the signs and symptoms of: Moderate to severe rheumatoid arthritis (RA) in adults. Humira can be used alone, with methotrexate, or with certain other medicines. Humira may prevent further damage to bones and joints and may help the ability to perform daily activities.
Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 4 years of age and older. Humira can be used alone, with methotrexate, or with certain other medicines.
Psoriatic arthritis (PsA) in adults. Humira can be used alone or with certain other medicines. Humira may prevent further damage to bones and joints and may help the ability to perform daily activities.
Moderate to severe adult Crohn's disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to conventional treatments. Humira is also used to reduce signs and symptoms and achieve clinical remission in these adults who have also lost response to or are unable to tolerate infliximab.
Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in children 6 years and older when certain other treatments have not worked well enough.
In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if Humira is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.