Amgen's, JJ's Anemia Drugs Get Stronger U.S. Warning

[cureisontheway]

Amgen’s, J&J’s Anemia Drugs Get Stronger U.S. Warning (Update4)

reposted from: http://www.bloomberg.com/apps/news?pid=20601087&sid=aqLc.tP3A6AI&refer=home

By Luke Timmerman

March 9 (Bloomberg) — The anemia drugs Aranesp and Epogen, made by Amgen Inc., and Procrit, sold by Johnson & Johnson, will get stronger warnings about serious health risks including death, the U.S. Food and Drug Administration said.

The FDA also said today it is “re-evaluating” the safety of the drugs. The agency is telling doctors to use the lowest doses needed to help patients avoid blood transfusions, said Richard Pazdur, the head of the FDA’s cancer drug office, in a news conference.

“There are many questions that need to be looked at, including additional clinical trials,” Pazdur said.

Aranesp is Amgen’s biggest-selling product, generating $4.12 billion for the Thousand Oaks, California-based biotechnology company last year. Aranesp and Epogen together accounted for 47 percent of the company’s revenue in 2006. Procrit, Johnson & Johnson’s version of Epogen, had $3.18 billion in sales.

Shares of Amgen fell $1.31, or 2.1 percent, to $60.86 at 4 p.m. in Nasdaq Stock Market composite trading. Shares of Johnson & Johnson, based in New Brunswick, New Jersey, gained 42 cents to $62.14 in New York Stock Exchange composite trading.

Anemia drugs are the “largest and most lucrative market in biotech,” and sales are growing at least 6 percent to 8 percent a year, said Jason Kantor, an analyst with RBC Capital Markets, in a January research report. The drugs are used to treat anemia, mostly for people with kidney disease and cancer patients undergoing chemotherapy.

Study Findings

Studies found that higher-than-approved doses of the drugs targeted by the FDA increased the risk of death, blood clots, strokes and heart attacks in those with chronic kidney failure, the agency said. Excess doses led to rapid tumor growth in people with head and neck cancer.

The drugs are usually prescribed to boost levels of hemoglobin in the blood to 12 grams a deciliter, the approved dose. Doctors may now want to go “no higher” than 10 or 11 grams per deciliter, Pazdur said.

“If the target for hemoglobin is in the 10-range, then that’s definitely going to have an impact for Amgen,” said Bill Tanner, an analyst with Leerink Swann in New York, in a telephone interview. Tanner’s firm has done consulting for Amgen in the past year, and he doesn’t own any shares.

Epogen is the single biggest drug expense for Medicare, the U.S. health plan for the elderly and disabled. Members of Congress have urged Medicare to change the way it pays for the medicine to eliminate incentives for giving higher doses.

`More is Better’

“This idea that `if some is good, more is better’ is an unfortunate theme that runs across American medicine,” Peter Eisenberg, a cancer physician in Marin County, California, said in a telephone interview. “The more stuff we doctors sell, the more money we make. That’s another problem.”

The drugs are also used by some cancer patients not on chemotherapy. Use of Aranesp for that purpose was removed in February from a list that Medicare and insurers follow for reimbursement. Analysts estimate that as much as $500 million a year of Aranesp sales come from that use.

The contractor for Medicare in Northern California, Illinois, Massachusetts, Maine and Vermont today stopped paying for Aranesp for cancer patients not in chemotherapy. Medicare often influences coverage decisions of private insurers.

Medicare pays close attention to FDA safety warnings, said Leslie Norwalk, acting administrator of the Centers for Medicare and Medicaid Services, in a statement. “We will carefully examine our policies for coverage” of anemia drugs.

Company Responses

Amgen said in a statement that new information accompanying Aranesp and Epogen will urge doctors to let patients know of the “increased risks of mortality” when the drug is given in ways that are not FDA-approved.

The company plans to update its marketing materials to reflect the new warnings, said Trish Hawkins, a company spokeswoman. Amgen’s anemia drugs are used by about 250,000 cancer patients a year, Hawkins said.

“Patient safety is unquestionably our top priority,” said Roger Perlmutter, Amgen’s head of research and development, in a statement.

Ortho Biotech, the Johnson & Johnson unit that markets Procrit, also will change its information for physicians to include the new information, said spokeswoman Stephanie Fagan.

“It is too early to speculate” on the financial impact of the FDA warning, Fagan said.

Class of Drugs

The FDA’s renewed scrutiny will apply across the class of drugs to which Aranesp, Epogen and Procrit belong. The treatments are genetically engineered forms of the protein erythropoietin, which is made by the kidney and increases the number of red blood cells.

Roche Holding AG is attempting to develop a rival product in the class, Cera, and has applied for FDA approval.

The FDA will hold a meeting of cancer experts on May 10 to seek advice on the drugs, Pazdur said.

Epogen was first approved by the FDA in 1989, and became Amgen’s first big-selling drug. Procrit is sold by Johnson & Johnson under a marketing agreement with Amgen. Aranesp, a drug modified for less-frequent dosing, was approved in 2001. The FDA said it revised the warning labels on the products in 1997, 2004 and 2005 when new information about safety came to light.

Procrit TV commercials in 2001 told consumers the drug could boost their energy and provide “strength for living.” The camera showed an elderly woman, who at first was too tired to sew her daughter’s wedding dress, dancing at the wedding thanks to Procrit, according to an article in the FDA’s consumer magazine.

Ortho Biotech stopped running the TV ads two years ago, Fagan said.

To contact the reporter on this story: Luke Timmerman in San Francisco ltimmerman@bloomberg.net .

Last Updated: March 9, 2007 18:28 EST

[Zoe]

I am concerned about the health risks, but I personally think I am more concerned about insurance being pulled. Even with my insurance, Aranesp costs me $1700 a month. No way can I afford full price, and I am feeling really good on it. I don’t want to go back to how I was feeling. Since I am not on chemo, looks that the insurance company pulling out may be down the road. It is just bad news all around.

Feeling discouraged,
Zoe

[chuckk333]

I would hope that the MDS foundation and the AA & MDS foundation would be on top of it and will be all over the FDA and Medicare to allow the use of these drugs on MDS patients. Lets be in touch with their patient support departments to urge their action

[Alice S]

I would like to hear what the MDS Foundation thinks because Mom just had 12 Eprex injections (3 months)and her doctor has just got approval from my parents medical aid for a double dose over 12 months (2 injections every week for 12 months) this despite the fact that after 3 months there was no improvement, infact she felt worse until she started taking the Goji berry supplements! Now I am really worried as her blasts were at 10% July 2006. I have emailed the above article to her and ordered her to have a BMB asap and to discuss this with her Hematologist. Mom is otherwise healthy and I would really not like to see her get sick if it can be avoided.
Thanks to all of you here. Keep posting. My thoughts and prayers are with you all.
Alice

[patti]

Alice,

Whatever you do I would push back against them giving her a double dose of this stuff. My MIL took it for 9 months and had zero improvement. It just wasn’t going to help my MIL. But in that 9 months we fully believe in increased her disease. She went from tranfusing every 12 weeks to every 2-3 weeks. That’s a signficant change. My MIL’s NP believes that the procrit (exprex for you) increased her disease rapidly and when we stopped the procrit the disease progression slowed down. I think procrit has a place if it works for folks but if it hasn’t worked for your mom yet it’s not likely too. And if it’s not working on her cells, it’s likely working against them (making them more leukemic in the long run). JMHO

patti

[eve]

my dad’s hemodoc said that if he did not see improvement with procrit shots after several months he should definitely get off of it as it could really do some harm

procrit didn’t work for dad before he started vidaza – in conjuction with the vidaza it seemed to work

eve

[Bec]

Hey all, My Dad went on procrit for 6 months in 2003. His Dr. took him off of it because he was having headaches, sores and other problems. We thought these symptons were due to procrit so asked Dr. to removve Dad from procrit. This was before we started txs. We think we may have made a mistake removing procrit because my Dad started having to have tx every two to three weeks.

Two years ago, after a bad heart surgery, Dad went back on procrit and last week set record for 11 weeks with no tx. We think the combonation of procrit, predinsone, and vytorin and prayer have contributed to Dads better health. Note that all these meds were prescribed by three different Dr. Dad gets 60,000 units of procrit weekly. How many deliliters is a unit???

Who do we contact to fight the discontinuation of this drug? Please let me know.

Thanks to you all
Bec

[Alice S]

Thanks Patti, I have spoken to my mother, she will request a BMB tomorrow and discuss a few related issue with her Hematologist. I would just like to add, for the record, that my mothers EPO level is normal, her Hematologist thought that perhaps ‘normal’ was not enough. Bec, Eve if the EPO is helping your Dads (x2) then I hope the drugs are not discontinued. As we are learning here, every single patient with MDS is unique!
Thanks to you all.
Patti, keep up the good work!
Take care everyone.
Alice

[chuckk333]

Contact both the MDS forum and the AA & MDS forum asking for their help in fighting the discontinuing of the medicare and insurance companies approval for payment for this drug for MDS.

Chuck

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