Tnf Blocker

FDA orders tougher warnings on TNF drugs

Tracy Staton — Fri, 05 Sep 2008 11:06:40 -0400

Forty-five deaths have prompted the FDA to demand new warnings on TNF inhibitors. The agency received reports of 241 cases of the fungal infection histoplasmosis in patients taking the drugs, which are used to treat rheumatoid arthritis and other autoimmune disorders. Among them were 45 patients who died. In at least 21 cases, doctors didn't diagnose the problem and treatment was delayed; 12 of those cases were fatal.

The drugs--Remicade from Johnson & Johnson; Humira from Abbott Laboratories; Cimzia from UCB; and Enbrel, co-marketed by Amgen and Wyeth--already carry warnings of infection risk, including a specific warning about tuberculosis.

But the FDA wants specific language about histoplasmosis and other fungal infections, particularly because doctors appear to have overlooked them in those 21 patients. Twenty percent of the patients who developed the infections died, but more than half of those treated late didn't make it.

- check out Amgen and Wyeth's statement
- see the WSJ Health Blog post
- read the story in the New York Times

FDA panel blesses new Enbrel use

Tracy Staton — Thu, 19 Jun 2008 08:36:06 -0400

The safety concerns recently raised about TNF blockers in general and Enbrel in particular weren't enough to keep the Amgen drug down. An FDA advisory panel voted 7-5 in favor of using Enbrel in children with moderate-to-severe psoriasis. As you know, it's already approved for use against rheumatoid arthritis in children and adults, and against psoriasis in adults. It pulled in $3.2 billion in 2007 revenues.

The vote follows an announcement earlier this week that the FDA aims to strengthen the warning labels on Enbrel. The agency wants to flag the risk of death among children and of moderate-to-severe infections in adults. That's because the agency found in its database a series of serious malignancies, infections, and neurological problems in pediatric patients who took Enbrel (a.k.a. etanercept).

Meanwhile, the agency is studying the entire class of drugs--the tumor necrosis factor blockers--for possible links to childhood cancers, especially lymphoma, in kids treated for RA or Crohn's disease. Enbrel is one of those drugs; the others approved in the U.S. are Humira (Abbott Laboratories), Remicade (Johnson & Johnson), and Cimzia (UCB).

- here's re release
- read the Washington Post story
- see the piece at CNN Money

FDA checks arthritis meds for child-cancer link

Tracy Staton — Thu, 05 Jun 2008 09:30:02 -0400

In a development sure to spawn headlines across the country, the FDA is looking into a possible link between autoimmune drugs such as Remicade and Humira--known as TNF blockers for their action against tumor necrosis factor--and childhood cancers. The meds are already labeled with potential cancer risks for adults, but this is the first time the FDA has analyzed the risk in patients up to 18 years old. Why now? We're not sure, given that 30 reports of cancer in children and adolescents trickled into the FDA over the 10 years since the first TNF blocker was approved.

It's not a huge cognitive leap: TNF blockers do their job by suppressing the TNF protein, an immune-system component that causes inflammation. It also is potentially helpful against tumor cells. But these meds aren't for lightweight diseases, either. Thousands of kids take Amgen and Wyeth's Enbrel and Abbott Laboratories' Humira for rheumatoid arthritis, a serious and painful disorder that erodes joints. Johnson & Johnson and Schering-Plough's Remicade is approved for kids with Crohn's disease, which, left untreated, can destroy the intestines' ability to absorb nutrients. The FDA said in a statement that it believes the benefits of the drugs outweigh the risks--but also recommended that doctors consider the potential cancer link when prescribing.

FDA says the review will take about six months. Analysts are already hand-wringing over a possible black-box warning; Humira was Abbott's best-seller last year, with $3 billion in sales, and Remicade delivered $1.65 million to Schering-Plough. (The number of adults using these meds far outweighs the juvenile use, though.) Expect to hear more discussion of the possible cancer link June 18, when an agency advisory panel hashes over Amgen's application to market Enbrel for kids with psoriasis.

- see the FDA release
- read the story in the New York Times
- check out the Washington Post article
- get the Chicago Tribune's focus on Abbott
- find Amgen and Wyeth's response