Pfizer to Withdraw Fablyn NDAs

Written by JANE ALLIN
Research Analyst

For every 150 women who stop taking Premarin, one mare is spared from the “pee line” and seven or eight “byproduct” foals may not be slaughtered for their meat.

Pfizer, the world’s largest drug maker, has announced the withdrawal of its new drug application (NDA) for Fablyn® a selective estrogen receptor modulator (“SERM”) for the treatment of both osteoporosis and selected consequences of menopause. As with other SERMs, Fablyn® has been shown to have significant side-effects which contraindicate widespread use.

In September of 2005, Fablyn® was rejected by the FDA due to elevated risks of uterine cancer and then in January of 2009 failed to win US approval due to increases in combined fatalities from all types of cancer in addition to strokes.

Pfizer said that it is exploring strategic options for Fablyn®, including out-licensing or sale.

In the EU, Fablyn® received approval from the European Commission in February 2009, and Viviant® under the trade name Conbriza®, for the treatment of post-menopausal osteoporosis in women at increased risk of fracture in April 2009.

http://www.stockmarketsreview.com/news/7912/
http://www.hotstocked.com/8-k/ligand-pharm-LGND-290621.html

What has this got to do with horses?

Meanwhile, other potential candidates for the treatment of post-menopausal osteoporosis are awaiting approval – Pfizer’s Viviant ® and Pfizer/Ligand Pharmaceuticals’ Aprela®. Viviant® is a “SERM” and Aprela® is Viviant® + Conjugated Equine Estrogens (CEEs) as iFH called attention to in an earlier article: “Aprela®: The Lesser Evil?

In keeping with other SERMs, Viviant® is not without issues and its approval for sale has been delayed by the FDA citing concerns pertaining to data collection and reporting and elevated incidence of stroke and venous thrombotic events. With any luck, these findings in conjunction with the inherent risks of CEEs and now the retraction of Fablyn’s® NDAs will jeopardize the FDA’s approval of Viviant® and Aprela® in North America.

And, what about Pfizer/Wyeth’s recent announcement that they will seek to resize the local Canadian PMU industry which will see the number of equine ranches dwindle from the current 64 to as few as 25?

The next couple of years may prove to be an interesting storyline for Big Pharma and the PMU mares and foals!

7 thoughts on “Pfizer to Withdraw Fablyn NDAs”

  1. I wrote this great screenplay, and am trying to get the movie made. It depicts a young woman discovering the truth about PMU, who then tries to rescue one lot of foals. Subplots are a HRT patient diagnosed with cancer, and the psychological battle of a family dealing with shame and regret for the abused animals. Hoping someone would pick this up to snuff out PMU the rest of the way. I think popular media and the movies need to take the real issues in our country on and make a positive difference w/ some popular art. Though the budget of one movie could support a rescue operation for life! Still, I am a storyteller, and I think cinema and TV, and popular trends, are the other governing body in this country- with extreme power and responsibilty.

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      1. Thanks, V!
        I think it used to be easier to do that with movies, in particular, but now it’s about dollars not ideals as much. It is one of my missions to turn the big screen back on to being the mass cultural catalist it can be! At least, a sector of it.

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  2. What really frosts me in all this is there are effective alternatives, even within allopathic (conventional) medicine. We have become a society of pill-takers, driven by pharmaceutical companies, their proprietary drugs, and their unceasing pressure on the medical community and legislators.

    Sure, other therapies may take more time and personal effort to work, but they can be much less toxic and stressful on the body. Conventional docs can’t prescribe or recommend them as effective because they haven’t been tested in FDA-approved clinicals. Some docs, including my dad’s (prostate cancer – thankfully in remission), say, “You know, I’ve heard something about XYZ.” Docs have to chose their words carefully not to run afoul of the FDA, but more and more are planting the seed. Then it’s up to patients to investigate and make their own decisions.

    Drug companies have mounted lawsuits to ban alternative medicine from the U.S. because they can’t get patents unless they come up with proprietary (and extremely profitable) drugs. They often use herbs and homeopathic techniques as base ingredients, and then give them a twist so they can be patented.

    I am vehemently opposed to these actions, but Pharmacutical Companies have deep pockets, powerful lobbiests and savvy lawyers. Soon our opportunity to chose alternative therapies may become illegal. Yet another assault on our freedoms.

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  3. I’m gonna step up on my soapbox and wax Old Skool – women should be in charge of their body mechanisms and resort to chemical ‘additives’ only in extreme cases; doctors & other medical practioners should be your back-up & partner.
    Women should be encouraged to research, to explore and make the most informed decisions for themselves.
    Women who are medical professionals should grab their sisters by the hand and share the knowledge.
    I’m not a radical feminist but I have daughters and granddaughters and I want the very best future for them and that does NOT include being experimental guinea pigs or fodder for the pharmaceutical industry.

    And each and every day on Earth should be a Spare the Mare Day.

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  4. All Premarin or Pee line Mares and their foals should be turned over to a horse organization that will take care of them and let them live their lives in peace. There are many synthetic drugs out there that will have the same affect. They don’t need to abuse these mares and their foals any longer. Pfizer and all drug companies should be ashamed and embarrassed for continuing the production of these unnecessary pills and the Pee line facilities should be made illegal world wide – not just in the United States. Any country that condones this should be banned from trading with or support by the USA PERIOD.

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    1. You are so right. We have been working hard on this issue, and hope to see this horrible decades old trail of abuse and death finally, finally over.

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