EMEA approves Prolia for marketing in Europe

According to a report from Reuters and a media release on the Amgen web site, the European Medicines Agency (EMEA) has approved denosumab (Prolia®) for marketing in Europe.

As far as prostate cancer is concerned, denosumab is approved for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. This approval does not immediately make the drug available in every European country because those decisions are made by individual nations, but approval by EMEA is a necessary first step before a new drug can be made available anywhere in Europe,

This is the first approval of denosumab by an regulatory agency. Amgen and its partners will now have to convince doctors, patients, and payers that denusumab is a “better” drug than zoledronate (Zometa) and others as an agent to prevent bone loss and fractures in patients being treated with hormonal therapy.

Denosumab was also approved by EMEA for the treatment of osteoporosis in postmenopausal women at increased risk of fractures. Action on denosumab by the US Food and Drug Administration for similar indications is expected in July this year.

2 Responses

  1. It was recommended my mother, age 86, use Prolia. She had radiation but it was for a non-cancerous tumor called a meningioma located on C5 C6 of the spine. The radiation was after conventional neurosurgery.

    She was left with a small portion of the tumor because the nerves that control the right side of her body were attached to the tumor. It has been a year since her surgery but the radiation about 10 months. Why is Prolia recommended for people who have received radiation?

  2. Dear Irene:

    I have no expertise whatsoever in the management of meningioma. However, Prolia (denosumab) is a drug that is used to try to prevent bone deterioration and fractures. Any women of your mother’s age is at risk for bone fractures, and with the combination of cancer in her spine, her age, and the radiation, I am guessing that her doctors would be quite worried about her risk for spinal deterioration and fracture. You really should ask your mother for permission to call her doctor and find out presisely why s/he prescribed the Prolia.

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