Health Boards
Sat-24-09-2011, 13:10 PM
Johnson & Johnson (JNJ) won U.S. approval for an expanded use of Remicade to treat children with a chronic inflammatory bowel disease who don’t respond to traditional therapy.
The Food and Drug Administration cleared the medicine chemically known as infliximab for pediatric ulcerative colitis, the company said today in a statement.
Remicade was approved in 1998 as the first anti-tumor necrosis factor (TNF)-alpha treatment in the U.S. It is used in Crohn’s disease in adults and children, and ulcerative colitis, rheumatoid arthritis and psoriasis in adults. Most children with ulcerative colitis are first treated with anti-inflammatory drugs and with steroids, according to the Pediatric IBD Foundation.
“Ulcerative colitis can be a devastating disease and previously, there had been no approved therapeutic options for pediatric patients who had an inadequate response to conventional therapy,” Jeffrey Hyams, head of digestive diseases and nutrition at Connecticut Children’s Medical Center, said in the statement from New Brunswick, New Jersey-based J&J.
Hyams, also a professor of pediatrics at the University of Connecticut School of Medicine, was the lead investigator in a company-sponsored study that showed 73 percent of children with ulcerative colitis responded to the drug within eight weeks.
About 150,000 children younger than age 17 are living with the symptoms of inflammatory bowel disease, J&J said. Ulcerative colitis can slow growth in children and delay sexual maturation, according to the Mayo Clinic based in Rochester, Minnesota.
Serious Risks
While the drug’s approval provides a new treatment option for children with moderate to severe ulcerative colitis, there are “serious risks” associated with its use because it suppresses the immune system, Donna Griebel, director of the FDA’s Division of Gastroenterology and Inborn Errors Products, said in a statement.
The drug carries a boxed warning, the FDA’s strongest caution, for increased risks of cancer and viral, fungal or bacterial infections.
A rare, often fatal type of cancer called Hepatosplenic T- cell Lymphoma is among malignancies that have been reported in adolescent and young adult patients using TNF blockers, the agency said in the statement.
An FDA advisory panel on July 21 backed Remicade for pediatric ulcerative colitis to induce and maintain clinical remission and induce mucosal healing. The panel didn’t recommend the therapy to maintain mucosal healing or eliminate corticosteroid use. The medicine generated $4.6 billion in revenue last year, according to data compiled by Bloomberg.
Source: bloomberg.com
The Food and Drug Administration cleared the medicine chemically known as infliximab for pediatric ulcerative colitis, the company said today in a statement.
Remicade was approved in 1998 as the first anti-tumor necrosis factor (TNF)-alpha treatment in the U.S. It is used in Crohn’s disease in adults and children, and ulcerative colitis, rheumatoid arthritis and psoriasis in adults. Most children with ulcerative colitis are first treated with anti-inflammatory drugs and with steroids, according to the Pediatric IBD Foundation.
“Ulcerative colitis can be a devastating disease and previously, there had been no approved therapeutic options for pediatric patients who had an inadequate response to conventional therapy,” Jeffrey Hyams, head of digestive diseases and nutrition at Connecticut Children’s Medical Center, said in the statement from New Brunswick, New Jersey-based J&J.
Hyams, also a professor of pediatrics at the University of Connecticut School of Medicine, was the lead investigator in a company-sponsored study that showed 73 percent of children with ulcerative colitis responded to the drug within eight weeks.
About 150,000 children younger than age 17 are living with the symptoms of inflammatory bowel disease, J&J said. Ulcerative colitis can slow growth in children and delay sexual maturation, according to the Mayo Clinic based in Rochester, Minnesota.
Serious Risks
While the drug’s approval provides a new treatment option for children with moderate to severe ulcerative colitis, there are “serious risks” associated with its use because it suppresses the immune system, Donna Griebel, director of the FDA’s Division of Gastroenterology and Inborn Errors Products, said in a statement.
The drug carries a boxed warning, the FDA’s strongest caution, for increased risks of cancer and viral, fungal or bacterial infections.
A rare, often fatal type of cancer called Hepatosplenic T- cell Lymphoma is among malignancies that have been reported in adolescent and young adult patients using TNF blockers, the agency said in the statement.
An FDA advisory panel on July 21 backed Remicade for pediatric ulcerative colitis to induce and maintain clinical remission and induce mucosal healing. The panel didn’t recommend the therapy to maintain mucosal healing or eliminate corticosteroid use. The medicine generated $4.6 billion in revenue last year, according to data compiled by Bloomberg.
Source: bloomberg.com
