FDA Approves Prolia™ for Postmenopausal Women at High-Risk for Fracture
"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, the first and only FDA-approved RANK Ligand inhibitor, is an every six month 60 mg subcutaneous injection administered by a health care professional (PR Newswire, June 1, 2010)."
"Prolia binds RankL preventing RankL-induced activation of osteoclasts. Prolia is a monoclonal antibody against RANK ligand (RANKL), a protein which activates osteoclasts to break down bone. Thus, like bisphosphonates, Prolia is an anti-resorptive therapy but with a different mode of action than bisphosphonates. (Boston Health News Examiner, photo courtesy of The New England Journal of Medicine June 4, 2010)." Click control and + sign to enlarge photo.
This monoclonal antibody medication comes on the heels of approval in Europe last week, for postmenopausal women who are at high-risk for osteoporosis. High-risk patients are those with a history of fractures, multiple risk factors for fracture, or patients who are intolerant to other osteoporosis medications.
Patients should be screened for hypocalcemia, prior to administration, since Prolia can exacerbate pre-existing low blood calcium levels. For this reason, hypocalcemia must be corrected prior to administration. Patients receiving this type of treatment should include supplementation of calcium and vitamin D daily, however those with hypocalcemia should see safety precautions and discuss calcium intake with their doctor.
Because there is a concern about osteonecrosis of the jaw with prolonged use, patients contemplating tooth extraction, dental implants or invasive dental surgery should consult with their doctor or oral surgeon about this procedure prior to administration of this medication.
As with all medications, Prolia has shown common and adverse side effects during the clinical trial of this drug, which are listed below.
Common Side Effects:
- Back pain
- Extremity pain
- Musculoskeletal pain
Adverse Side Effects:
- Hypocalcemia (in 1.7% of the Prolia group)
- Serious Infections ( in 3.3% of placebo group and 4.0% in the Prolia group)
- Dermatological adverse reactions (in 8.2% in placebo and 10.8% in the Prolia group)
- Osteonecrosis of the Jaw
- Pancreatitis (in 0.8% of the Prolia group)
"The significance of these findings and the effect of long-term treatment with Prolia are unknown (Prolia Prescribing Information, June 2, 2010)."
At this time, no drug interaction studies have been conducted with Prolia.
Prolia is not recommended in pediatric patients or nursing mothers.
One of the possible limitations with osteoporosis medications is the problem with compliance. The weekly and monthly medications have postural and food restrictions that make it difficult to take. Also, as we age we tend to forget to take something on a daily or weekly basis, so for this reason some switch to monthly regimes, quarterly or annual/biannual infusions. Since Prolia will be administered twice a year, it will make the process much easier to handle.
The price for this biannual injection will be $825.00 per injection.
This injection can be administered at a doctor's office, by a health care professional. Prolia is administered, via injection, in the abdomen, upper arm, or upper thigh.
Since this was approved for patients at high-risk, we'll have to see what type of preliminary screening might be conducted by the patient's doctor to receive patient approval for use. Usually high-risk patients must have a low t-score, history of fractures or intolerance of other osteoporosis medications.
Treatment with Prolia produced bone mineral density increases at three years of, 8.8% lumbar spine, 6.4% total hip, and 5.2% at femoral neck. "Prolia was effective in reducing the risk for new morphometric vertebral fractures regardless of age, baseline rate of bone turnover, baseline BMD, baseline history of fracture, or prior use of a drug for osteoporosis (Prolia Prescribing Information June 2, 2010)."
For those who choose this type of treatment Amgen has initiated, "The Prolia Post-marketing Active Safety Surveillance Program which is available to collect information from prescribers on specific adverse events. Please see http://www.proliasafety.com/ or call 1-800-772-6436 for more information about this program (Prolia Prescribing Information, June 2, 2010)."
Post-marketing Active Safety Surveillance Program
Photo courtesy of: The New England Journal of Medicine 2006