UPDATE: FDA: Requires Stronger Warnings For TNF Blocker Drugs
04 Août 2009 - 9:43PM
Dow Jones News
The Food and Drug Administration said Tuesday there's an
increased risk of lymphoma and other cancers associated with the
use of drugs like Remicade and Humira in children and
adolescents.
The agency said a new cancer-related warning will be added to
the boxed-warning that's already on the drugs, which are known as
tumor necrosis factor, or TNF blockers. The boxed warning, which is
the FDA's strongest drug warning, currently warns of the risk of
developing serious infections that can be fatal.
The drugs, which also include Enbrel, Cimzia and Simponi, are
approved to treat various immune system diseases including juvenile
idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis,
plaque psoriasis, Crohn's disease and ankylosing spondylitis. As a
class, TNF blockers are among the top selling drugs in the U.S.,
according to IMS Health, with Enbrel and Remicade having a combined
$6.5 billion of U.S. sales in 2008.
The drug labels previously discussed a possible risk of cancer.
The drugs suppress the immune system by blocking TNF, a substance
in the body that causes inflammation and can lead to various
immune-system related diseases.
The FDA said it was working with manufacturers - including a
unit of Johnson & Johnson (JNJ), which makes Remicade and
Simponi, Abbott (ABT), the maker of Humira and Amgen (AMGN) and
Wyeth (WYE) which co-market Enbrel - to define the risk of cancer
in children and adolescents.
Cimzia, made by UCB SA's (UCB.BT), and Simponi are currently
approved for use in adults. UCB was previously asked by FDA to
conduct a multi-year study looking at long-term cancer risk
associated with Cimzia. Last June the FDA announced it was
conducting a safety review of the TNF blockers after receiving
about 30 reports of cancer in children and young adults over a
10-year period who had been treated with one of the TNF blockers
and other drugs like methotrexate that also suppress the immune
system starting before age 18.
The agency said about half of the cancers were lymphomas, a
cancer of cells in the immune system, and included both Hodgkin's
and non-Hodgkin's lymphoma.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com