PROLIA® (denosumab) now approved for the treatment of osteoporosis in men

• PROLIA receives TGA approval and recommendation for PBS listing^1,2
• PROLIA is the only approved osteoporosis treatment that targets RANK Ligand, an essential regulator of osteoclast formation, function and survival¹
• In Australia, one in three men over the age of 60 will suffer from an osteoporosis-related fracture³

Amgen Australia and GlaxoSmithKline Australia (GSK) today announced the Therapeutic Goods Administration (TGA) has approved a new indication for PROLIA^® (denosumab), the only Australian approved RANK Ligand inhibitor, as a treatment to increase bone mass in men with osteoporosis at increased risk of fracture.¹

PROLIA has already been recommended to be listed on the PBS by the Pharmaceutical Benefits Advisory Committee (PBAC) for men with a minimal trauma fracture, or men aged 70 or over with a BMD T-score of -2.5 or less.²

“Osteoporosis and osteoporosis-related fractures are commonly associated with postmenopausal women with few recognising that the condition can affect men,” said Professor Peter Ebeling, Head of Endocrinology, Western Health.

“In reality, one in three Australian men over the age of 60 will suffer from an osteoporosis-related fracture, and for those who do suffer an osteoporosis induced fracture, their life expectancy is more likely to be reduced compared with women. Fracture prevention is crucial to the overall health of men living with the condition.”

Osteoporosis is a systemic skeletal disease that causes the bones to become thin, weak and
fragile.⁴ Osteoporosis affects 1.2 million Australians and according to Osteoporosis Australia, 23% of those with osteoporosis are men,^3,5 with one in three over the age of 60 suffering an osteoporosis induced fracture.3 For those with osteoporosis, it can be a major cause of pain, disability and premature death.³

PROLIA has a mechanism of action unlike other osteoporosis treatments. Administered every six months as a subcutaneous injection, PROLIA is the only therapy that targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone). Through highly specific inhibition of RANK ligand, PROLIA decreases bone resorption, and improves bone density at all measured skeletal sites.¹

“Having administered PROLIA to postmenopausal women with osteoporosis for a number of years now, we welcome any new treatment that will help our male patients as often they are not as readily diagnosed and their condition is less well managed,“ said Dr John Barlow, General Practitioner, Bankstown Medical Centre, NSW.

“Compliance and adherence to treatment remains an issue for our patients with osteoporosis. PROLIA assists patients to be compliant with their medication as it is a twice-yearly injection administered by their GP or practice nurse.”

The new indication for PROLIA is based on results from the ADAMO trial (A Multicenter Randomised Double-blind Placebo Controlled Study to Compare the Efficacy and Safety of DenosumAb versus Placebo in Males with Osteoporosis), the pivotal Phase 3 study involving 242 men with low bone mineral density (BMD). In the study, 1 year of treatment with PROLIA 60mg every 6 months resulted in significantly greater gains in BMD when compared to placebo at the lumbar spine (5.7 percent vs. 0.9 percent, p<0.0001), hip (2.4 percent vs. 0.3 percent, p<0.0001), femoral neck (2.1 percent vs. 0.0 percent, p<0.0001) and trochanter (3.1 percent vs. 0.8 percent, p<0.0001). Effects of PROLIA on BMD were independent of age, baseline testosterone levels, baseline BMD status and estimated 10 year fracture risk.⁶

Safety Information
The most common adverse events reported in the ADAMO trial, occurring in at least 5% of PROLIA-treated men and more frequently than in the placebo-treated patients were: back pain (8.3% PROLIA, 6.7% placebo), arthralgia (6.7% PROLIA, 5.8% placebo), and nasopharyngitis (6.7% PROLIA, 5.8% placebo).¹

Precautions: Hypocalcaemia must be corrected prior to starting PROLIA. Patients receiving PROLIA may develop skin infections, any signs and symptoms of cellulitis should be treated. Osteonecrosis of the jaw has been reported rarely in clinical studies in patients receiving PROLIA at a dose of 60 mg every 6 months for osteoporosis. Good oral hygiene practices should be maintained during treatment with PROLIA.¹

Contraindications: Hypocalcaemia. Hypersensitivity to denosumab, Chinese Hamster Ovary (CHO)-derived proteins or to any component of the medicine.¹

About Osteoporosis in Australian Men
Osteoporosis affects 1.2 million Australians and according to Osteoporosis Australia, 23% of those with osteoporosis are men,^3,5 with one in three over the age of 60 suffering an osteoporosis induced fracture.³

Osteoporotic fractures can lead to a variety of complications, including pain, reduced quality of life, immobility and loss of independence, in addition to premature death.^3,4 In fact, over one in four people who suffer a hip fracture will die within 12 months of the event, and less than one third will regain their pre-fracture mobility.³

While osteoporosis does affect more women than men, when fractures occur in men it is more likely to shorten their lifespan.⁷

Notes to Editor:
Please review full Product Information before prescribing as attached and also available on request from 1800 803 638.
PBS Information: This product is not listed on the PBS for male osteoporosis

Please review full product information before prescribing.

MINIMUM PRODUCT INFORMATION

INDICATION: #Treatment to increase bone mass in men with osteoporosis at increased risk of fracture. CONTRAINDICATIONS: Hypocalcaemia. Hypersensitivity to denosumab, CHO-derived proteins or any component. PRECAUTIONS: Correct hypocalcaemia prior to initiating therapy. Monitor calcium in patients predisposed to hypocalcaemia. Adequate intake of calcium and Vitamin D is important. ADVERSE EFFECTS: Hypocalcaemia, skin infections (predominantly cellulitis), pancreatitis, rarely jaw osteonecrosis, #very rarely atypical femoral fractures. DOSAGE AND ADMINISTRATION: Single subcutaneous injection of 60 mg, once every 6 months. Ensure adequate intake of calcium and Vitamin D. No dose adjustment required in the elderly or in renal impairment. PRESENTATION: Pre-filled syringe with automatic needle guard. #Please note changes in Product Information. Product Information is available by contacting Amgen Australia on 1800 646 998 or via http://www.amgen.com.au/Prolia.PI.

Prolia^® is a registered trademark of Amgen. Amgen Australia, Level 7, 123 Epping Road, North Ryde, NSW 2113, ABN 31 051 057 428. www.amgen.com.au. GlaxoSmithKline Australia, Level 4, 436 Johnson St, Abbotsford, VIC. ABN 47 100 162 481. www.gsk.com.au.

REFERENCES:
1. Prolia^® (denosumab) approved Product Information. 5 September 2013. http://www.amgen.com.au/Prolia.PI
2. Australian Government Department of Health and Ageing. July 2013 PBAC Outcomes – Positive Recommendations. http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-outcomes/2013-07/positive-recommendations. [Last accessed online 25 September 2013].
3. Medical Journal of Australia. 4 February 2013. Building healthy bones throughout life: an evidence-informed strategy to prevent osteoporosis in Australia. https://www.mja.com.au/open/2013/2/1/building-healthy-bones-throughout-life-evidence-informed-strategy-prevent-osteoporosis [Last accessed online 11 September 2013].\
4. AIHW 2011. A snapshot of osteoporosis in Australia 2011. Arthritis series no. 15. Cat. no. PHE 137. Canberra: AIHW. http://www.aihw.gov.au/publication-detail/?id=10737418750 [Last accessed online 11 September 2013].
5. Osteoporosis Australia. http://www.osteoporosis.org.au/about/about-osteoporosis/men/ [Last accessed online 10 September 2013].
6. Orwoll E et al. J Clin Endocrinol Metab. 2012; 97: 0000–0000
7. Andrology Australia. https://www.andrologyaustralia.org/osteoporosis/ [Last accessed online 10 September 2013].

About Amgen
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realise the promise of new science by bringing safe, effective medicines from laboratory 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, bone disease and other serious illnesses.

About GSK
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