J&J’s Remicade Backed by FDA Committee for Approval in Pediatrics

Earlier on Thursday, Johnson & Johnson’s Remicade (infliximab), which is administered to pediatric patients with moderately to severely active ulcerative colitis and inadequate response to conventional therapy, was recommended for approval by the FDA advisory committee.

Data from a Phase III trial that established a clinical response in 73 patients after eight weeks of Remicide therapy was reviewed by panel members. On the basis of this data, panelists noted that the approval of the drug for this indication was favored by its benefit-risk profile. In addition, the data obtained was consistent with those from previous clinical trials in adults thus confirming Remicide’s safety profile.

However, the panelists cautioned that patients should be warned about the risks associated with the drug because safety concerns including serious infection and the development of lymphoma and other cancers, associated with the drug and others in its class have not yet been fully explored.

Further, according to reports, adolescent or young adult male patients who were consuming thiopurines experienced nearly 40 incidences of hepatosplenic T-cell lymphoma.

Remicide that made $3.1 billion in US sales in 2010, is approved for use in Crohn’s disease in adult and pediatrics as well as and several other indications.