On June 1, 2010, Amgen inc. announced, that the U.S. Food and Drug Administration (FDA) has approved Prolia™ (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk of fracture or patients who intolerant to other osteoporosis therapy. Prolia™ is the first RANK Ligand inhibitor approved by FDA. Given as 60 mg subcutaneous injection every six months, Prolia™ reduced the risk of fracture.
Kevin Sharer, chairman of the board and chief executive officer of Amgen, said the approval is the culmination of a scientific journey, which was lasted for more than 15 years ago when Amgen discovered the path of bone metabolism. The result of this journey is Prolia™, the medication which will help women with postmenopausal osteoporosis at high risk of fracture and the company is more than proud to make it available for physicians and their patients.
Treatment with Prolia™ showed stronger bones, greater bone density, reduced risk of non-vertebral, hip and vertebral fractures measured at three years. There are nearly 8,000 postmenopausal women with osteoporosis took part in the research Phase 3.
President and chief operating officer of Amgen, Robert A. Bradway, pointed out Prolia™ to be not only an important keystone for Amgen but also even more important medication for patients with postmenopausal osteoporosis with the high risk of fracture. He said, that it was priced correctly, to reflect its therapeutic value and added, that expect to be it commercially available in the United States within the next week.
Felicia Cosman, M.D., clinical director of the National Osteoporosis Foundation and medical director of the Clinical Research Center at Helen Hayes Hospital in New York said, that the approval of the mediation marks the first new class of medicine introduced in nearly 10 years. She thinks, that it would be a welcome new option, because of its convenient twice a year shot and reduces the fracture risk at key sites.
The pivotal 3-year Phase 3 Fracture Reduction Evaluation of Denosumab in Osteoporosis every six Months (FREEDOM) study, where about 8,000 women with postmenopausal osteoporosis showed, that Prolia™ injections every 6 months compared with placebo at three years resulted in:
- 20% reduction in non-vertebral fractures; absolute risk reduction: 1.5%; the incidence of non-spine fractures: 8% placebo vs 6.5% Prolia™
- 68% reduction in vertebral fractures; absolute risk reduction: 4.8%; the incidence of new spine fractures: 7.2% placebo vs 2.3% Prolia™
- 40% reduction in vertebral fractures; absolute risk reduction: 0.3%; the incidence of new spine fractures: 1.2% placebo vs 0.7% Prolia™
- Bone density increase: 5.2% at the femoral neck, 6.4% at the total hip, 8.8% at the lumbar spine
Prolia™ is contraindicated in patients with hypocalcemia. This illness should be corrected prior to initiation the treatment with Prolia™. Hypocalcemia may worsen, especially in patients with renal impairment. In the pivotal study, serious infections leading to hospitalizations were reported more frequently in the patient group treated with Prolia™. Also, more frequently Prolia™ -treated group reported about serious skin infections, as well as urinary tract infections, ear infections, and abdomen infections. Patients should be advised to keep urgent medical attention if they see any symptom of the infection. Also, there were reports about epidermal and dermal events (rashes, eczema etc.)
The medication also resulted in a suppression of bone remodeling. The long-term consequences could include osteonecrosis of the jaw (ONJ), delayed fracture healing and atypical fractures. Patients should be monitored for such outcomes in order to get a medical help in time. Here’s the list of most common adverse reactions: pain in extremity, back pain, hypercholesterolemia, cystitis (it’s 5% more that in the placebo group).
In collaboration with FDA, Amgen created several programs to help doctors and their patients make right treatment decisions, based on the most complete and up-to-date Prolia™ benefit-risk information:
- Risk Evaluation and Mitigation Strategy (REMS) which consists of medication guide and communication plan for health care providers;
- Post-marketing surveillance; Amgen will continue to collect data for almost 10 years from women with postmenopausal osteoporosis who will have exposure to Prolia™. Also, Amgen will start international safety observational study for a long-term period for five countries to assess pre-specified adverse events of special interest; on the top of that, Prolia Post marketing Active Safety Surveillance Program will be launched.
Lack of treatment options for osteoporosis
In the United States, 50% of women over 50 years old with postmenopausal osteoporosis will experience a fracture in their remaining lives (need to say, this kind of fractures increase the kind for another fracture). This could have severe clinical consequences. In 2005, those fractures were responsible for about $19 billion in costs. In 2025 experts are waiting to this number rise up to $25 billion. Some patients are simply not tolerating to osteoporosis therapy. Poor adherence can also increase fracture risk and could be the cause of hospitalization.
Prolia™ is considered for the patients with postmenopausal osteoporosis at high risk of fracture, those patients with low tolerance to their therapies, or patients, who have failed their therapies before.
Amgen Inc. has launched product support program which is designed to assist health care providers, care givers, and their patients to facilitate access to Prolia™. ProliaPlus provides all the insurance coverage information to health care providers. Also, upon the request, ProliaPlus will tell patients and health care providers when is the time for the next Prolia™ doze. This should support patient adherence.
Based on wholesale acquisition cost, 60mg of Prolia™ will cost $825. This price is competitive with other therapies. Plus, this is the first and only therapy of this kind approved by FDA.
Prolia should be administered by a Health care professional, whether is covered under payers’ medical or pharmacy benefit. Amgen will support both benefits based on payer’s reimbursement decisions. The product also will be stocked at wholesalers within a week of approval and Amgen will re-supply the wholesalers, if needed. In addition, the single unit syringe will be available for health care providers to get it from the distributor. Because it was approved in June this year, patients are able to receive only one dose this year.
To view REMS materials and the Prolia Prescribing information, please visit: www.ext.amgen.com