Johnson and Johnson granted approval for Remicade

Healthcare company Johnson & Johnson has confirmed that its licensing application for a drug to be used in treating Crohn’s Disease (CD) has been marked as a priority.

A wholly-owned subsidiary of the global firm has received acceptance by the Food and Drug Administration (FDA) for its biologics licensing application regarding the use of Remicade (infliximab) as a therapy for CD in young patients who have not responded well to other remedies.

The priority status was given to the submission from Centocor following the publication of results from its phase III study of the drug, which found that 88.4 per cent of children with moderate to severe CD experienced a clinical response to treatment with Remicade within ten weeks.

“Remicade, if approved for the treatment of paediatric Crohn’s disease, would represent a major advancement for children with this serious condition,” commented Dr Jerome A Boscia, senior vice president for clinical research and development at Centocor.

He added that the Johnson & Johnson subsidiary firm is looking forward to cooperating with the FDA in its review process of the clinical trial data.

The company stated that almost 850,000 people worldwide have used Remicade for treating a range of conditions, including ulcerative colitis and rheumatoid arthritis.