Please login to the form below

Not currently logged in
Email:
Password:

FDA approves J&J's Remicade for children

Johnson & Johnson's Remicade (infliximab) has received approval from the US Food and Drug Administration (FDA) for the treatment of ulcerative colitis in children over six years of age

Johnson & Johnson's (J&J) Remicade (infliximab) has received approval from the US Food and Drug Administration (FDA) for the treatment of ulcerative colitis in children over six years of age who have not responded to conventional therapy.

The approval is supported by data from a phase III trial that showed treatment with Remicade induced clinical response in 73 per cent of patients at week eight and demonstrated similar results concerning safety as found in previous studies in an adult population.

The FDA said: "Remicade reduces signs and symptoms of UC and induces and maintains clinical remission in these patients."

Remicade is already approved by the FDA for over 16 indications, including the treatment of rheumatoid arthritis and Chrohn's disease. This is its seventh approval in the field of inflammatory bowel disease (IBD).

The drug carries a boxed warning for risk of serious infections and cancer, and Dr Donna Griebal, director of the Division of Gastroenterology and Inborn Errors Products in the FDA's Center for Drug Evaluation and Research, said there are "serious risks" associated with the drug's use.

The drug is still only authorised for use in adults with ulcerative colitis in Europe.

26th September 2011

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Sciterion

Sciterion is an award winning specialist healthcare communications consultancy within the Havas Health network of companies. We exist to make...

Latest intelligence

Navigating the antibiotic resistance crisis
Blue Latitude Health speaks to Tara DeBoer, PhD, Postdoctoral Researcher and CEO of BioAmp Diagnostics to explore the antimicrobial resistance crisis, and learn how a simple tool could support physicians...
Combined immunotherapies – potential and pitfalls
‘Combining therapeutic compounds is the first logical step towards better results, namely higher rates of patients responding to treatment, with deeper and more sustained responses’...
Report: Achieving launch excellence in the challenging healthcare markets of today
Our in-depth report is based on original data and expert interviews, which coupled with our own experience, ensures we give you the best recommendations for achieving launch success in challenging...

Infographics