Enbrel

Amgen defends Enbrel after J&J wins trial

Tracy Staton — Fri, 19 Sep 2008 10:27:29 -0400

A new Johnson & Johnson drug trial has put Amgen on the defensive. According to the 903-patient study, J&J's experimental drug ustekinumab (Stelara) proved more effective at treating psoriasis than Amgen's blockbuster Enbrel was. "We've never really seen clearance [of psoriasis] along the lines of what we've seen with ustekinumab," one of the trial's lead investigators told the Wall Street Journal.

Amgen fired back, saying that the J&J trial only lasted 12 weeks, and so it didn't address the new drug's long-term safety. Enbrel has a "consistent safety profile," an Amgen spokeswoman said, and 16 years of clinical experience. It's true that the FDA is digging into links between the fungal infection histoplasmosis and TNF-alfa meds, but only 17 of the 240 cases occurred among Enbrel patients. Stelara works via a different mode of action than Enbrel does: It's an interleukin inhibitor, rather than a TNF blocker.

Amgen's safety focus may be well targeted. The FDA recently delayed approving the J&J drug for three months, with a decision now expected in December; this after the FDA advisory panel unanimously recommended approval. The expert panel did discuss worries about possible cancer risks with Stelara, and according to the WSJ Health Blog, safety appears to be the FDA's overriding concern. “We have submitted a summary of safety data to the FDA but efficacy will probably not play a major role in the approval," a J&J biologics exec told the blog. We'll have to wait and see what the agency decides.

- read the WSJ story
- check out the article in Forbes

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

NICE wants to limit anti-TNF use

Tracy Staton — Mon, 21 Jul 2008 10:42:48 -0400

Hear those cries of protest? They're coming from the U.K., whose National Institute for Health and Clinical Excellence (NICE) issued guidelines today that would limit patients' access to high-tech arthritis meds. Under the guidelines, each patient could use only one of the anti-TNF drugs--Centocor's Remicade (infliximab), Abbott Laboratories' Humira (adalimumab), and Amgen's Enbrel (etanercept)--and couldn't try another if the first stopped working or didn't help in the first place.

NICE said that giving patients more than one of these meds is not cost-effective, and that if one of them doesn't work, then docs should use Roche's Rituxan--known as Mab Thera in the U.K. and Rituxan in the U.S. Rheumatoid arthritis activists rose to the anti-TNF drugs' defense, saying that a limit of one would amount to "one roll of the dice" and "rationing without rationality."

The guidelines aren't in force yet; a final version is due in September. Activists are hoping that the outcry convinces NICE to change its mind. It worked before; NICE proposed anti-TNF limits in 2006, but recanted after protest.

- see the BBC story
- check out the coverage in the Telegraph

Study: Enbrel plus methotrexate helps RA

Christe Bruderlin-Nelson — Wed, 16 Jul 2008 10:39:32 -0400

A new study published online by The Lancet on July 15, 2008, said that most patients taking a combination of Enbrel and methotrexate had no progression of joint damage halfway into a two-year study. The study included 542 patients with rheumatoid arthritis in Asia, Australia, Europe and Latin America. In the COMET (COmbination of Methotrexate and ETanercept in Active Early Rheumatoid Arthritis) study, infections and malignancies showed no difference between the trial group, who took etanercept (Enbrel) plus methotrexate, versus the group taking only methotrexate.

Amgen and Wyeth both have their hands in the pot on this one, as Amgen markets Enbrel in North America and Wyeth sells it everywhere else. Enbrel brought in $3.2 billion in 2007. This is good news for Amgen and Wyeth and follows an FDA warning last month about whether Enbrel, as well as other tumor necrosis factor inhibitors like J&J's Remicade, increase the risk of cancer in children.

- here's the report
- find out more from MarketWatch

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

Enbrel, antipsychotics draw warning fire

Tracy Staton — Tue, 17 Jun 2008 11:04:57 -0400

Warning! Warning! Two new safety stories from the FDA hit the press yesterday: One on Amgen's rheumatoid arthritis and psoriasis drug Enbrel, and one on older antipsychotic meds such as Haldol and Thorazine.

First, the agency wants to beef up labeling for Enbrel to include a warning that, when used in children, the drug carries the risk of death. Enbrel is up for pediatric approval for use in psoriasis--currently it's only approved for psoriasis use in adults -- and in preparation for the advisory committee discussion tomorrow, FDA staffers combed the adverse events database. They found some serious problems in kids using Enbrel, such as malignancies, infections, and neurological problems, many of them life-threatening--and some deadly. Given the fact that the number of children on Enbrel is fairly small, these serious adverse events are a red flag, FDA said. The agency is recommending that the label be changed, regardless of whether the drug gets the additional psoriasis nod.

Meanwhile, the FDA warned doctors that dementia patients using older antipsychotics appear to be at an increased risk of dying. A "black box" warning is going on the meds, which are sometimes used off-label to calm aggressive or out-of-control dementia patients. It's similar to the cautionary tale on newer antipsychotics, a.k.a. atypicals, which got a death-risk black box for dementia use three years ago.

- see the Wall Street Journal article
- check out the Washington Post story

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

Enbrel gets black-box infection warning

Fri, 02 May 2008 06:59:56 -0400

Enbrel's new black box is now official. Wyeth and Amgen have put the final touches on a boxed warning about tuberculosis and other life-threatening illness; the label states that patients using the drug have contracted infections that led to hospitalization and death. The drug is primarily used to treat psoriasis, but also is used for rheumatoid arthritis and other autoimmune disorders.

Amgen and Wyeth co-market Enbrel in the U.S. and Canada. The drug posted $3.2 billion in sales in 2007.

- see the CNN Money coverage

ALSO: According to the latest CEO ranking by Forbes magazine, which measured performance against pay for 175 company chiefs, Amgen's Kevin Sharer came in near the bottom of the barrel, at 169th. Report