By Lisa Seachrist
WASHINGTON — The FDA issued Centocor Inc. a completed review letter for infliximab, formerly known as Avakine, for the treatment of Crohn's disease.
The agency identified matters related to final labeling, an agreement for a post-marketing clinical trial and the pre-approval inspection of the manufacturing facility as issues which need to be resolved before infliximab can be marketed.
"We are very pleased that the agency could respond so quickly to our expedited review," said Christopher Allman, spokesman for Malvern, Pa.-based Centocor. "We are very positive about the content of the letter. Many of the issues are ongoing."
As a result of FDA reform, the agency no longer issues approvable or non-approvable letters to companies following review of their drugs, but instead issues "completed review" letters, which list deficiencies in the application that need to be corrected before the drug can be marketed.
Infliximab is a monoclonal antibody aimed at tumor necrosis factor alpha (TNF alpha), which has been implicated in a wide variety of inflammatory diseases, including rheumatoid arthritis and Crohn's disease — an autoimmune disease that causes inflammation of the mucosal lining in the gastrointestinal tracts.
Advisory Panel Backs Approval
In May, the Gastrointestinal Drugs Advisory Committee unanimously recommended approval of infliximab for Crohn's disease in patients for whom conventional therapy is inadequate and in patients who have draining fistulae — deep ulcer tracts that burrow through the bowel into surrounding tissue and out through the skin. The committee also said the drug should be approved for short-term use and recommended a long-term post-marketing study.
The FDA took the advice on the post-marketing study, requiring a Phase IV trial to examine extended patient use of the drug. Allman noted Centocor always intended to conduct such a trial. He said conversations with the FDA are ongoing about the trial's protocols.
In addition, Allman said the company already has submitted a response to questions raised following an April pre-market inspection of the manufacturing facilities. Centocor is awaiting further action from FDA on that issue.
"It took a lot of work by the agency to have everything ready for the advisory committee in May," Allman said. "We have been very pleased with the conversation we have had with the agency. One could describe our conversations as constructive."
Centocor's stock (NASDAQ:CNTO) closed Wednesday at $35, down $1.25. *