Psoriasis drug pulled yesterday

[portann]

"Genentech withdrew its psoriasis drug Raptiva from the market yesterday, citing the risk of developing progressive multifocal leukoencephalopathy (PML), a rare, often fatal brain infection. The drug will be phased out by June 8 of this year, according to a statement by the US Food and Drug Administration (FDA)."

http://www.the-scientist.com/templates/trackable/display/blog.jsp?type=blog&o_url=blog/display/55607&id=55607

The Scientist: NewsBlog:
Genentech pulls Raptiva
Posted by Tia Ghose
[Entry posted at 9th April 2009 03:27 PM GMT]
View comments(3) | Comment on this news story  

Genentech withdrew its psoriasis drug Raptiva from the market yesterday, citing the risk of developing progressive multifocal leukoencephalopathy (PML), a rare, often fatal brain infection. The drug will be phased out by June 8 of this year, according to a statement by the US Food and Drug Administration (FDA).



The decision comes after Genentech reported a fourth case of PML diagnosed in a 47 year old man in Germany in February, and a subsequent warning by the FDA. Three other people taking Raptiva have developed PML, two of whom died.

Raptiva is an antibody therapy that reduces psoriasis flare-ups by suppressing T-cells. Sales of the drug were $108 million in 2008, and about 2,000 people are currently taking it, according to a statement by Genentech.

The withdrawal won't hurt Genentech's bottom line much, said Simos Simeonidis, a senior biotechnology analyst and director at Rodman & Renshaw, LLC. "It was not ever a major source of revenue for Genentech, especially in the psoriasis indication...I think actually the effect right now will be null," he said

Last month, the FDA unanimously recommended approval for the use of Genentech's anti-cancer drug Avastin for glioblastoma multiforme, a deadly form of brain cancer. The expanded market for Avastin will likely outweigh the loss of revenue from Raptiva, he said, adding that Genentech's recently completed merger with the pharma giant Roche won't be affected.

PML primarily affects people with weakened immune systems, spurring a normally harmless virus, called Polyomavirus JC, to destroy the myelin sheaths surrounding nerves in the brain. There is no known treatment for the infection. Seven patients have also developed PML while taking Biogen Idec's multiple sclerosis drug Tysabri.


Related stories:
Psoriasis drug sickens patient
[23rd February 2009]
MS drug sickens patient...again
[16th December 2008]
Genentech Builds a Blockbuster-free Road to Billions
[7th June 2004]





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comment:
All antibodies used for treatment of chronic diseases should be very careful
by anonymous poster

[Comment posted 2009-04-09 15:55:23]


Theoretically all antibodies to the targets (antigens) expressed by any normal tissue cells should not be useful for any therapy, except for short treatment of acute diseases. The antibodies currently used for cancer therapy are also questionable for long term effects.




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comment:
Not SO Voluntary
by Ross Miles

[Comment posted 2009-04-09 15:28:28]


This article appears to have been written by Genentech.

Consider this:Published February 20, 2009

? In consultation with Health Canada, EMD Serono Canada Inc., the company that markets
RAPTIVA in Canada will suspend RAPTIVA from the Canadian marketplace due to safety
concerns.?

In addition: ?A benefit/risk analysis conducted in Europe by the European Medicines Agency (EMEA)
has determined that the benefit/risk in the approved indication for RAPTIVA has become
unfavourable following safety concerns.?

http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/medeff/raptiva_2_hpc-cps-eng.pdf

Then The Scientist reports on February 23, 2009, ?Psoriasis drug sickens patient?
? Tara Cooper, spokesperson for Genentech, said, "As a company, we take the risk of PML very seriously and we're working with the FDA to put the right plan in place to protect people's safety.?

http://www.the-scientist.com/blog/display/55444/

The lawyers were already lurking on February 20:

http://www.consumerinjurylawyers.com/legal-news/raptiva-europe-sales-suspension/index.html

Looks like a pushed volunteer to me, and a little late at that, since the EMEA is expected to follow Canada.





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comment:
PML also stands for promyelocytic leukemia protein
by anonymous poster

[Comment posted 2009-04-09 12:27:53]


See recent articles
1: Jul-Larsen A et al. Cell-cycle regulation and dyn...[PMID: 19339552]
2: Louria-Hayon I et al. E6AP promotes the degradation...[PMID: 19325566]
3: Wojiski S et al. PML-RARalpha initiates leukem...[PMID: 19322209]
4: Nichol JN et al. Expanding PML's functional re...[PMID: 19273202]
5: Virador VM et al. The human promyelocytic leuke...[PMID: 19058256]
6: Hansen LA et al. A PMLRARA transgene results i...[PMID: 14500356]

[lalapple]

thanks so much Portann for this info, i've been having slight psoriatic like rashes from certain medications i was on before i realized it could be due to allergies as well.  one of my very close family members also has psoriasis and i'm afraid it could be hereditary.

[hippygem]

Hi

Billy Goat Soap will get rid of the psoriasis, and its also good for eczema etc.  This stuff works, believe me.

It can be bought at the Health stores.