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Fda: Pfizer Osteoporosis Drug's Benefits Outweigh The Risks by sgbvdf asga
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Fda: Pfizer Osteoporosis Drug's Benefits Outweigh The Risks |
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(PFE) to submit applications for osteoporosis New Drugs Useful in patients with postmenopausal women, but also pointed out the drug should be limited to the risk of fracture in women with severe or for other treatment options in patients with non-sensitive patients to use.
Pfizer is requesting the U.S. Food and Drug Administration has approved for the treatment of postmenopausal women with osteoporosis drug Fablyn listing request. Osteoporosis is often considered a leading culprit in patients with fractures. U.S. Food and Drug Administration said nine members of the group, Fablyn benefits greater than its risks, but three dissenting members of the group, while one member abstained.
However, Brown University (BrownUniversity) gynecology professor Sandra - Carson (SandraCarson) that the U.S. Food and Drug Administration panel of patients in general that the drug treatment of osteoporosis for women provides a new choice, and Other osteoporosis drugs usually there are several side effects. The drug is particularly conducive to a serious risk of fracture in postmenopausal female patients.
U.S. Food and Drug Administration urology and director of reproductive health products Scott - Monroe (ScottMonroe) pointed out that the views of members of the group did not explicitly reject the drug's listing application, "but did not clear that agreed to this request. "
Is not clear whether the U.S. Food and Drug Administration approved the drug to market requests, and whether the drug would be recommended limited use in certain female patients. U.S. Food and Drug Administration will make decisions in reference to the views of all members of the group, its decision in October there is some time before. If Fablyn listing request was turned down, and Pfizer will be a big blow, as many analysts predict sales of the drug may be as high as 10 billion dollars.
Pfizer spokesman Jack - Cox (JackCox) said in a statement, Pfizer believes Fablyn with serious risk of fracture in postmenopausal women with osteoporosis have a unique advantage.
Fablyn working mechanism of the female hormone Hormone Similar, only some parts in the human body will not affect other parts. Such drugs are called selective estrogen receptor modulator, can generate a positive impact on some organizations, while not have the adverse effects of estrogen. Eli Lilly (EliLilly & Co.) (LLY) Evista osteoporosis drugs belonging to these areas.
U.S. Food and Drug Administration officials in pre-session documents were put forward their own concerns, that Fablyn lead to the risk of death than placebo patients, but most members said they think there is enough information to confirm this .
Members Clifford - Rosen (CliffordRosen) pointed out that "I am disappointed that we did not see" Fablyn and has received FDA approval of drugs direct comparison between the experimental data. Osteoporosis Rosen is the center of Maine senior scientist. He believes that there is no direct comparison with other experimental drugs, "we are in fact difficult to determine with certainty what a drug effective for any drugs ineffective."
Pfizer pointed out, resulting in increased mortality in patients taking Fablyn reason seems to be taking placebo during the experiment caused by an abnormally low mortality.
Women's rights groups on behalf of the public part of the meeting was also made a speech, clearly opposed Fablyn.
"Obviously the benefits of the drug is minimal," Washington non-profit organization American Women and Family Research Centre (NationalResearchCenterforWomen & Families) President Diana - Zucherman I am an expert from China Toys Suppliers, usually analyzes all kind of industries situation, such as long sleeve bridal gown , tailor made dresses.
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