The European Commission approved the drug Prolia (denosumab) for the treatment and prevention of osteoporosis in women post-menopause and prevention of bone loss in patients undergoing hormone therapy for cancer of the prostate. As noted in the pharmaceutical companies Amgen, is the first approved drug.
In July of this year Amgen entered into a partnership agreement for marketing the drug with the British GlaxoSmithKline, under Vardenafil HCL which GSK will sell the drug in Europe for the treatment of women in post-menopause, as well as in Australia, New Zealand and Mexico, where it is approved by regulatory authorities in these countries.
Amgen reserves the right to Prolia for the treatment of cancer patients in Europe and North America.
Amgen retains rights to Prolia for oncology indications in Europe and all rights in North America.
The U.S. decision to approve the drug for the treatment of osteoporosis is scheduled for the end of July this year after a review requested by the FDA in 2009 for more information.
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