Oct 3 U.S. health regulators have approved
Pfizer Inc's menopause drug Duavee, which is designed to
reduce hot flashes with fewer side effects than older
The Food and Drug Administration said on Thursday it
approved the drug to treat women with moderate to severe
menopause symptoms and to prevent post-menopausal osteoporosis,
a bone disease which can increase the risk of fractures.
The drug, which Pfizer is developing with Ligand
Pharmaceuticals Inc, combines bazedoxifene - which
belongs to a class of drugs known as selective estrogen receptor
modulators, or SERMS - and conjugated estrogens, which are
derived from the urine of pregnant horses and contained in the
hormone replacement drug Premarin.
U.S. Census data from 2000 indicate there are about 37.5
million women reaching or currently at menopause, which
typically occurs between the ages of 40 and 59, according to the
Centers for Disease Control and Prevention.
Conjugated estrogens have been shown to increase the risk of
uterine cancer, blood clots and strokes. Combining estrogens
with progestin therapy can increase the risk of heart attacks,
strokes, breast cancer and blood clots.
The FDA said the bazedoxifene component of the drug reduces
the risk of endometrial hyperplasia, or excessive growth of the
lining of the uterus. But the product's label will carry a boxed
warning, the most serious type, reflecting the risk of
Use of hormone therapy dropped significantly following the
2002 release of safety data from a big study published by the
Women's Health Initiative.
The FDA said Duavee is only intended for post-menopausal
women who still have a uterus and should be used for the
shortest duration possible. If the drug is used only to prevent
osteoporosis, "such use should be limited to women who are at
significant risk of osteoporosis after carefully considering
alternatives that do not contain estrogen."
The drug is expected to generate sales of only $161 million
by 2017, according to Thomson Reuters data.