This month, Pharm Exec magazine presents its Brand of the Year. Here, Brittany Agro profiles one of the runners-up, Amgen’s osteoporosis treatment, Prolia.
A joint meeting of the European Calcified Tissue Society and the International Bone and Mineral Society, held June 2005 in Geneva, Switzerland, revealed promising developments for more effective treatments in bone heath—specifically geared toward the “silent epidemic,” osteoporosis.
Five years later, on June 1, 2010, the FDA approved Amgen’s Prolia (denosumab), the first biologic medication for treatment of postmenopausal women with osteoporosis at high risk for fracture.
This decision came one year after the Agency originally delayed the drug’s approval. The reason cited: Amgen needed to show a new clinical program to support approval of the drug’s prevention indication.
They didn’t waste any time.
Commitment to Safety, Achievement
The company, with FDA’s aid, quickly developed a Risk Evaluation and Mitigation Strategy (REMS) to help patients understand the drug’s risks. The REMS included a communication plan for healthcare providers and a medication guide for patients, comprehensive post-marketing surveillance, and a post marketing Active Safety Surveillance Program to monitor the long-term safety of Prolia. In addition, Amgen set up a surveillance program to monitor more than 4,500 women who already were taking the drug.
And that’s just the beginning of a march forward. With these improvements came honorable mentions.
Not only was Prolia named one of Time magazine’s Top 10 medical breakthroughs of 2009 but it also won the Best New Drug award at the 2010 Scrip Awards. The Scrip judges highlighted Prolia’s efficacy in reducing fractures and dosing regimen.
A Bona Fide Answer to Osteoporosis
A scientific journey that started more than 15 years ago, Prolia is administered as an injective every six months to reduce risk of fracture at the spine, hip, and other sites. Normally, the body is charged to break down and rebuild bone as needed. Low estrogen levels in postmenopausal women unbalance this process in favor of bone breakdown. Prolia halts this process.
During its three-year study, 7,808 postmenopausal women ages 60 to 91 were put on a trial. The study (funded by Amgen) concluded Prolia reduced the incidence of vertebral, non-vertebral, and hip fractures in postmenopausal women with osteoporosis.
It should be noted that Prolia isn’t the first injectable osteoporosis drug, however. It’s a new type. Two bisphosphonate medications, Reclast and Boniva, are also delivered intravenously. Forteo and Miacalcin, require self-injections.
For patients intolerant to other available osteoporosis therapies, Prolia is the only FDA-approved RANK ligand inhibitor, an essential regulator of osteoclasts (the cells that break down bone)—and its sales are soaring as a result. The drug generated $9.95 million in sales from launch through September 2010, according to IMS Health.
The total direct medical cost of osteoporosis in Europe has been estimated at more than €36 billion annually, and is expected to increase to €76.7 billion in 2050. In May 2010, Prolia was granted marketing authorization in the EU—perhaps one of the more significant unique selling points of the drug. It is the first and only approved treatment in Europe for bone loss due to hormone ablation in men with prostate cancer.
Prolia’s European approval in all 27 EU member states, as well as Norway, Iceland, and Liechtenstein, led to the first approval of the product worldwide.
Only time will tell how the drug impacts patients who are seeking long-term relief. For now, Prolia is representing promising efforts of science—and pharma is standing proudly behind it.