CONFUSED!!!??? Is BZA = Pfizers NEW Duavee???

cp418 · October 2013

The FDA late Thursday approved bazedoxifene/conjugated estrogens (Duavee) to treat moderate-to-severe hot flashes related to menopause in women who haven't had a hysterectomy. Check MedPage Today later in the day for more coverage on the approval.

http://www.bloomberg.com/news/2013-10-03/pfizer-ligand-win-u-s-approval-for-hot-flash-therapy.html

I just got off the phone with a Pfizer Customer Inquiries rep discussing access to BZA in the USA. She said it was not approved and could not give me any information about this drug. Now I find this article today for Duavee (approved bazedoxifene)!!!!

Is anyone else as confused as me!!!??? This new drug is COMBINED WITH conjugated ESTROGEN - - so I would think anyone with breast cancer hx should NOT take this medication.

cp418 · October 2013

http://online.wsj.com/article/PR-CO-20131003-910561.html

Pfizer Inc. Announces FDA Approval of DUAVEE(TM) (conjugated estrogens/ bazedoxifene) for the Treatment of Moderate-to-Severe Vasomotor Symptoms (Hot Flashes) Associated with Menopause and the Prevention of Postmenopausal Osteoporosis

cp418 · October 2013

http://www.medscape.com/viewarticle/812080

FDA Okays Duavee for Hot Flashes, Osteoporosis

http://www.fda.gov/Drugs/NewsEvents/ucm370679.htm

http://www.rttnews.com/2198164/pfizer-announces-fda-approval-for-duavee-therapy-quick-facts.aspx?type=fdp

leggo · October 2013

Confusing, yes....and also very weird that Wardells didn't make mention of any of this in his/her posts on the subject.

cp418 · October 2013

My guess is Duavee(TM) is the same or similar medication approved in Europe for post-menopause women. However, the combination of estrogen in this drug prevents it's use for breast cancer patients who are hormone receptor positive. Of course, this was the whole intent of our petition to Pfizer. IMO - Pfizer went after the post menopause market $$$$$$$$$$ which is far larger than the breast cancer market. So we know clearly their priority for which patients it was intended for and we frankly are the minority..... We are pleading for orphan drug use here.

Note - Evista will off patent soon so Duavee will compete in the post menopause market. Interesting timing.

http://community.breastcancer.org/blog/how-breast-cancer-drugs-are-developed-the-bazedoxifene-story/

leggo · October 2013

Sorry, didn't mean to minimize anything, if that's how it came across. I just find it odd that my physician knew the intricate details of this drug, but a "researcher" didn't. In any event, I sincerely hope it's approved for off-label compassionate use for those who can use it. Thank you for doing all the work.

cp418 · October 2013

There is probably much information decided internally within big pharma and biotech companies regarding where they will invest their future drug market. Very competitive market and research going on. IMO supporting researchers and many people internal to these companines know nothing of the higher up decisions being made. The person I spoke to this morning could have been discussing any drug -- she would not/ could not answer direct questions about BZA. What a surprise a short while later to stumble upon todays news for Duavee.........

CONFUSED!!!??? Is BZA = Pfizers NEW Duavee???

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