Humira

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

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

Alzheimer's: A new indication for Enbrel?

Thu, 10 Jan 2008 06:59:56 -0500

For yet another example of the trend toward teaching old drugs new tricks, check out Exhibit E for Enbrel. According to research released today, the anti-rheumatoid arthritis med has shown an amazing ability to rehabilitate Alzheimer's patients.

Made by Amgen, Enbrel is a TNF-alpha inhibitor, and excess TNF-alpha has been found in the cerebrospinal fluid of Alzheimer's patients. Previous research has shown that Enbrel injected into the spine of patients can cause marked improvement in symptoms that lasts up to six months. The new data , published in the Journal of Neuroinflammation, focuses on one man whose relief began within 10 minutes of the injection. Suddenly, he could remember things he'd been unable to recall before treatment, and his score on a common symptom assessment more than doubled.

Much larger studies are needed before any talk of getting a new indication for Enbrel--or its TNF-inhibitor counterparts Humira, made by Abbott Laboratories, and Remicade, made by Johnson & Johnson subsidiary Centocor. But don't expect this sort of research to stop with Alzheimer's. Considering the role inflammation plays in many diseases, we may see researchers throwing TNF-alpha inhibitors at all sorts of conditions, just to see what might stick.

- get the scientific details
- read the report from the BBC
- get more from the Journal of Neuroinflammation

Related Articles:
Amgen reps allege marketing abuse. Report
MAbs are hottest segment of biotech industry. Report
New vaccine may stop, slow Alzheimer's. Report

ALSO NOTED: Did Merck, Schering withhold Zetia data?;Genentech gives eye docs access to Avastin

Fri, 21 Dec 2007 06:59:50 -0500

> Merck and Schering-Plough research raised questions about potential liver damage from their popular cholesterol med Zetia--but the companies never published those studies. News about this unpublished data comes on the heels of a delay in results from an important new Zetia trial. Report

> Genentech and its eye-doctor critics have buried the hatchet, at least partly. The company will allow ophthalmologists to order its cancer drug Avastin from wholesalers and then send it to compounding pharmacies to be repackaged for use against macular degeneration. Report

> Massachusetts has pledged $40.5 million in incentives to Shire, to persuade the British drug maker to follow through on an expansion project in Lexington that would create hundreds of jobs. Report

> The European Commission is on the verge of handing $2.9 billion to the Innovative Medicines Initiative, which will pair up with academics and pharma industry types to develop new drugs. Release

> Abbott Laboratories got the regulatory nod to sell its psoriasis treatment Humira in Europe. Report

> Millennium Pharmaceuticals filed for FDA approval to market Velcade for previously untreated multiple myeloma. Release

And Finally... Do we need drugs for shyness, or do shy folks just need practice making conversation? Report

ALSO NOTED: NICE rejects Remicade for ankylosing spondylitis; Mom sues drugmaker over infant's death;

Thu, 15 Nov 2007 06:59:50 -0500

> Britain's National Institute for Clinical Excellence rejected Schering-Plough's Remicade as a treatment for ankylosing spondylitis, recommending Abbott's Humira and Wyeth's Enbrel instead. Report

> A mother is suing J&J company McNeil and Walgreen's, alleging that her infant son died after using the companies' cough-and-cold remedies. Report

> Awaiting the FDA's yea or nay on its new blood pressure drug, Sciele Pharma saw its stock rise on an analyst upgrade to "neutral" from "underperform." Report

> Medtronic got the FDA's nod for a stent system aimed at cancerous tumors in the bile duct; the product will launch immediately. Report

> Schering-Plough opened its new Canadian HQ today in Montreal. Report

> The fallout over Merck's disastrous AIDS trial continues. There are new reports out that other developers have put their trials on hold while researchers and the FDA ponder the safety issues posed by Merck's program. Report

> Nastech Pharmaceutical is laying off workers and restructuring its operations. In addition, Nastech's RNAi business is being spun off into a separate, publicly traded biotech. Report

And Finally... Look out, Big Pharma. Presidential candidate John Edwards wants to nix patents and give cash prizes instead. Report

NICE snubs Orencia, picks 3 rivals

Fri, 26 Oct 2007 06:59:54 -0400

It's final: Britain's National Health Service won't pay for Bristol-Myers Squibb's anti-arthritis drug Orencia. Patient advocacy groups had been lobbying the National Institute for Health and Clinical Excellence to reconsider its earlier recommendation to pass over the drug because it's too expensive.

Meanwhile, NICE recommended Abbott Laboratories' Humira, Amgen's Embrel, and Johnson & Johnson's Remicade for treatment-resistant arthritis. Individual patients will be monitored every six months to make sure the drugs are working; if not, they'll be discontinued.

-read the news release from NICE (pdf)
-read NICE's guidance at its website
-read the story in The Guardian
-read more in the Independent

Antibody sales growing fastest

Fri, 12 Oct 2007 06:59:54 -0400

Looking for pharma growth? Here it is--in monoclonal antibodies. A new Datamonitor report projects 14 percent annual growth in the market for the antibody drugs, which mimic the body's own immune system. That's by far the fastest-growing segment of the industry.

It's easy to see why, when you recite a list of drugs that fall under this umbrella: Avastin, Herceptin, Remicade, Humira and Rituxan. Monoclonal antibodies sell at the rate of $20 billion annually; by 2009, Datamonitor predicts, that figure will be $34 billion. The only caveat? The "big five" drugs mentioned above will still account for most of the market--some 70 percent in 2012.

- check out the Datamonitor report for more

Related Articles:
FDA approves Rituxan for rheumatoid arthritis. Report
FDA approves Avastin for lung cancer. Report
Remicade approved for psoriatic arthritis. Report
FDA approves expanded use of Humira. Report
Erbitux clears late-stage hurdle for lung cancer. Report

SPOTLIGHT: NHS approves drugs

Wed, 22 Aug 2007 06:59:52 -0400

British patients on the National Health Service will get access to two intensive arthritis therapies: MabThera, made by Roche; and Humira, made by Abbott Laboratories. Patient advocacy groups have been lobbying for the drugs since the National Institute for Health and Clinical Excellence (NICE) refused to add Orencia, a similar medication, to the NHS formulary. Release