Remicade moves closer to approval for use on children

Johnson & Johnson announced that REMICADE for the treatment of Crohn's disease in children has been accepted for Priority Review by the U.S. Food and Drug Administration (FDA).

The filing is based primarily on Phase 3 study results showing the unprecedented efficacy of REMICADE® in the treatment of children with moderately to severely active Crohn's disease. In the REACH [...] trial, nearly 90 (88.4 percent) of pediatric patients with moderately to severely active Crohn's disease who had an inadequate response to conventional therapy achieved clinical response at week 10 when treated with REMICADE®. Nearly two-thirds (63.5 percent) of the patients who were randomized to treatment with REMICADE® every eight weeks were in clinical response at one year. Additionally, more than half of the patients treated with REMICADE® every eight weeks were in clinical remission at the end of one year.

Priority review is explained by the FDA:

Prior to approval, each drug marketed in the United States must undergo a detailed FDA review process. The FDA has been classifying the likely benefit of a drug since the 1970s, initially in three categories: (A) a major advance over available treatments, (B) a modest advance, or (C) no real advance. More recently, the classification has been in two categories: a real advance (priority or P), or about the same effectiveness as available therapies (standard or S).

In 1992, under the Prescription Drug User Fee Act (PDUFA), a law that requires fees be paid by drug manufacturers when they submit an application to market a drug, the FDA agreed to specific goals for completing its review and taking action on drugs. These goals were different for priority and standard drugs.

For standard drugs, which offer at most only minor improvement over existing approved therapies, review and action were to be completed in 12 months. The 2002 amendments to PDUFA changed that goal to 10 months.

Priority drugs, or those that offered a significant improvement over marketed treatments or provided a treatment where no adequate therapy existed, were given a six-month review and action goal.