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Amgen Gets FDA Approval for Prolia – Treatment for Post Menopausal Women With Osteoporosis High Risk

Posted Jun 01 2010 4:32pm

During the clinical trials one injection was administered as a 60mg every six months, and with the price quoted in the press release of $850.00 per injection it’s not an inexpensive item and hopefully insurance may cover some or all of this.  If I want to be tacky this cost compares with the average cost of what men pay for an ED drug cost for a year, so in those terms it’s not out of the cost arena.  image

Being an injection you get twice a year, this also makes it easier than taking pills too and trying to remember.  The press release also stated the product should be out within a week. 

THOUSAND OAKS, Calif., June 1, 2010 /PRNewswire via COMTEX/ --Amgen Inc.today announced that the U.S. Food and Drug Administration (FDA) has approved Prolia(TM) (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. Prolia, the first and only FDA-approved RANK Ligand inhibitor, is an every six month 60 mg subcutaneous injection administered by a health care professional.

"Today's FDA approval of Prolia is the culmination of a scientific journey that started more than 15 years ago with Amgen's discovery of an essential pathway that regulates bone metabolism," said Kevin Sharer, chairman of the board and chief executive officer of Amgen. "Prolia is the result of this discovery and offers an important new medicine for postmenopausal women with osteoporosis at high risk for fracture. Amgen is proud to make this new treatment option available to physicians and patients." 

Prolia's approval is based on a pivotal three-year Phase 3 study involving 7,808 postmenopausal women with osteoporosis. Treatment with Prolia resulted in greater bone density, stronger bones, and reduced risk for vertebral, hip and non-vertebral fractures measured at three years.(i)

Prolia Clinical Data

The pivotal three-year Phase 3 Fracture REduction Evaluation of Denosumab in Osteoporosis every six Months (FREEDOM) study in 7,808 women with postmenopausal osteoporosis demonstrated that Prolia, administered as a 60mg subcutaneous injection every six months, compared with placebo at three years resulted in: (ii)

  • A 68 percent reduction in vertebral fractures (4.8 percent absolute risk reduction). The incidence of new spine fractures was 2.3 percent with Prolia vs. 7.2 percent with placebo;
  • A 40 percent reduction in hip fractures (0.3 percent absolute risk reduction). The incidence of hip fractures was 0.7 percent with Prolia vs. 1.2 image percent with placebo;
  • A 20 percent reduction in non-vertebral fractures (1.5 percent absolute risk reduction). The incidence of non-spine fractures was 6.5 percent with Prolia vs. 8 percent with placebo;
  • Significant bone density increases at all key sites measured (8.8 percent at the lumbar spine, 6.4 percent at the total hip, and 5.2 percent at the
  • femoral neck).

ProliaPlus is a multi-faceted product support program designed to provide comprehensive assistance to healthcare providers, patients, and their caregivers to help facilitate access to Prolia for appropriate patients.

ProliaPlus provides information and assistance on issues related to product insurance coverage to physician offices. Additionally, upon request, ProliaPlus will remind patients and providers about when the patient's next dose is due, thus helping to support patient adherence to therapy. ProliaPlus will also have information on the availability of potential financial assistance programs.

Prolia will cost $825 per 60 mg injection (based on "wholesale acquisition cost" or WAC). Prolia's price is competitive with other branded osteoporosis therapies while reflecting its positive clinical profile for patients at high risk for fracture.

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