28.05.2010 – 11:11
Prolia(R) (Denosumab) Granted Marketing Authorization in the European Union
Amgen Inc. today announced that the European Commission (EC) has granted marketing authorization for Prolia(R) (denosumab) for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. Prolia has been approved in all 27 European Union member states plus Norway, Iceland and Liechtenstein. The European approval of Prolia marks the first approval of the product worldwide.
"The European approval of Prolia is a significant medical advance for patients with bone loss conditions," said Will Dere, senior vice president and international chief medical officer at Amgen. "In particular, we believe that Prolia will offer patients with postmenopausal osteoporosis at increased risk for fracture an important alternative to current treatments. Prolia reduces the risk of fracture through a convenient injection given every six months. Amgen is proud to make this new treatment available to physicians and their patients."
The marketing authorization for Prolia comprises data from six Phase 3 trials, including two pivotal Phase 3 studies with fracture endpoints in the osteoporosis and prostate cancer settings, which demonstrated that Prolia administered as a 60mg subcutaneous injection every six months reduces the incidence of fractures. All six studies showed Prolia's ability to increase bone mineral density (a measure of bone strength) at all skeletal sites measured.
"Osteoporosis is a serious, chronic disease that can significantly impact the lives of millions of affected women. Despite widely available treatments, new options are still needed to help protect against fractures," said Professor Socrates E. Papapoulos, professor of medicine, consultant physician and director of bone and mineral research at the department of endocrinology & metabolic diseases of the Leiden University Medical Center, The Netherlands. "By targeting RANK Ligand, Prolia offers an innovative new approach that helps reduce fracture risk."
"The approval of Prolia in the European Union is great news for patients as it is the first and only product approved in Europe for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures," said Professor Bertrand Tombal, chairman of the division of urology and associate professor of physiology at the Universite catholique de Louvain (UCL), Cliniques universitaires Saint-Luc, Brussels, Belgium. "Bone loss can be a serious problem for men undergoing hormone ablation therapy for prostate cancer and if left untreated it can lead to fractures."
Results from 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 showed that women receiving a subcutaneous injection of Prolia every six months experienced a 68 percent reduction in the relative risk of suffering a new vertebral (spine) fracture compared to those receiving placebo as well as a 40 percent reduction in the relative risk of suffering a hip fracture and a 20 percent reduction in the relative risk of suffering a nonvertebral fracture at 36 months.(i)
Results from the pivotal HALT (Hormone Ablation Bone Loss Trial) study which evaluated change from baseline in lumbar spine BMD in 1,468 men undergoing androgen deprivation therapy (ADT) for non-metastatic prostate cancer showed that patients treated with Prolia experienced a 62 percent reduction in the relative risk of suffering a new vertebral fracture with Prolia compared to placebo at 36 months, with significant reduction observed as early as month 12.(ii)
Safety and Administration
The most common adverse reactions with Prolia were urinary tract infection, upper respiratory tract infection, sciatica, cataracts, constipation, rash, pain in extremity. The most serious adverse reactions were those of skin infections, predominantly cellulitis, reported more commonly in the Prolia group compared with placebo (0.4 percent vs. 0.1 percent) in postmenopausal osteoporosis studies. In breast and prostate cancer studies, serious adverse reactions of skin infection were similar in the Prolia and placebo groups (0.6 percent vs. 0.6 percent). In the Phase 3 placebo-controlled clinical trial in patients with prostate cancer receiving ADT an imbalance in cataract adverse events was observed with Prolia compared with placebo (4.7 percent vs 1.2 percent placebo). No imbalance in cataract adverse events was observed in postmenopausal women with osteoporosis or in women undergoing aromatase inhibitor therapy for nonmetastatic breast cancer.
The recommended dose of Prolia is 60mg administered as a single subcutaneous injection every six months.
Prolia (denosumab) has a unique mechanism of action. It is the first and only approved therapy that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone).
Prolia is under regulatory review in the United States (U.S.), Switzerland, Australia and Canada.
Often referred to as the "silent epidemic," osteoporosis is a global problem that is increasing in significance as the population of the world both increases and ages. The World Health Organization (WHO) has recently identified osteoporosis as a priority health issue along with other major non-communicable diseases.
An estimated 30 percent of all post-menopausal women in Europe have osteoporosis, and more than 40 percent of them will suffer osteoporotic fractures in their lifetime.(iii) Osteoporotic fractures can impose a significant financial burden to individuals and health services.(iv) The total direct medical cost of osteoporosis in Europe has been estimated at more than euro 36 billion annually, and is expected to increase to euro 76.7 billion in 2050 as the population ages.(v)
Along with proper diet and weight-bearing exercise, medications can help slow bone loss and reduce the risk of fracture.
About Cancer Treatment-Induced Bone Loss due to Hormone Ablation
Prostate cancer is the most common form of cancer in men in Europe and accounts for over 24 percent of cancer diagnoses.(vi) Prostate cancer patients undergoing ADT experience accelerated bone loss and an increased fracture risk. It is common for prostate cancer patients to receive hormone ablation therapies that can lead to a decrease in bone mass and increased risk of fractures. One in five men treated with hormone ADT for prostate cancer will experience a fracture within five years.(vii)
No other EMA-approved therapies currently exist for the management of bone loss due to hormone ablation therapy in patients with prostate cancer.
About Denosumab Collaborations
In July 2009, Amgen and GlaxoSmithKline (GSK) announced a collaboration agreement to jointly commercialize Prolia for postmenopausal osteoporosis in Europe, Australia, New Zealand and Mexico once the product is approved in these countries. Amgen will commercialize Prolia's postmenopausal osteoporosis and oncology indications in the U.S. and Canada and for all oncology indications in Europe and in other specified markets.
In addition, GSK will register and commercialize denosumab for all indications in countries where Amgen does not currently have a commercial presence, including China, Brazil, India and South Korea but excluding Japan. The structure of the collaboration allows Amgen the option of an expanded role in commercialization in both Europe and certain emerging markets in the future.
Amgen and Daiichi-Sankyo Company, Limited have a collaboration and license agreement for the development and commercialization of denosumab in Japan.
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit http://www.amgen.com.
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Editors Note: The FDA has provisionally approved the trade name Prolia(TM) for the proposed indications of treatment and prevention of osteoporosis in postmenopausal women, and treatment and prevention of bone loss in patients undergoing hormone ablation for non-metastatic prostate or breast cancer, for which denosumab is administered twice-yearly subcutaneously at a 60mg dose. The Prolia(TM) trade name is only for these indications and may not apply for other indications of denosumab.
To view the Prolia (denosumab) Summary of Medicinal Product Characteristics, click here: http://www.amgen.com.
CONTACT: Amgen, Zug, Switzerland Wendy Woods-Williams: +41-(41)-3692-542 (media, osteoporosis) Sabeena Ahmad: +41-(41)-3692-530 (media, oncology) Amgen, Thousand Oaks, California Sarah Reines: +1-805-447-9783 (media, osteoporosis) Christine Regan: +1-805-447-5476 (media, oncology) Arvind Sood: +1-805-447-1060 (investors) i Cummings SR, et al. Twice Yearly Denosumab, a Monoclonal Antibody to RANK-ligand, for Prevention of Fractures in Postmenopausal Women with Osteoporosis. N Engl J Med, 2009 Aug. 20; published online at www.nejm.org on Aug. 11, 2009.' ii Smith MR, et al. Denosumab for the Prevention of Bone Loss and Fractures in Men Receiving Androgen Deprivation Therapy in Non- Metastatic Prostate Cancer. N Engl J Med, 2009 Aug. 20; published online at www.nejm.org on Aug. 11, 2009. iii Epidemiology." International Osteoporosis Foundation. Accessed at http://www.iofbonehealth.org/health-professionals/about- osteoporosis/epidemiology.html on 10 March 2009. iv Cooper C. The crippling consequences of fractures and their impact on quality of life. Am J Med. 1997;103(2A):12S-17S. v "Facts and statistics about osteoporosis and its impact." International Osteoporosis Foundation. Accessed at http:// www.iofbonehealth.org/facts-and-statistics.html on 10 March 2009. vi Ferlay J, et al. Estimates of the cancer incidence and mortality in Europe in 2006. Annals of Oncology, 2007 Feb. 7. vii Shahinian VB, Kuo YF, Freeman JL, Goodwin JS. Risk of fracture after androgen deprivation for prostate cancer. N Engl J Med. 2005;352(2):154-64.
CONTACT: Amgen, Zug, Switzerland, Wendy Woods-Williams:
+41-(41)-3692-542(media, osteoporosis), Sabeena Ahmad:
+41-(41)-3692-530 (media, oncology),or Amgen, Thousand Oaks,
California, Sarah Reines, +1-805-447-9783 (media,osteoporosis),
Christine Regan, +1-805-447-5476 (media, oncology), ArvindSood,
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