Studies suggest that a first-of-its-kind osteoporosis drug lowers the risk of bone fractures better than some existing treatments and could soon add a more expensive but easier option to the booming market, The Associated Press reported.
Amgen Inc’s genetically engineered denosumab only requires two shots a year and could be approved for sale this fall.
Many osteoporosis patients stop taking other drugs due to side effects or frequent dosing. But doctors say denosumab’s high cost may be a drawback, due to competition with other cheaper and heavily advertised treatments currently on the market.
Dr. Sundeep Khosla, a professor and osteoporosis researcher at the Mayo Clinic, believes denosumab will find a particular niche where it will be used, but doesn’t see it taking over the market.
However, Khosla called it a “tour de force of modern molecular medicine” because it is potent and was designed specifically to block one pathway involved in the natural breakdown of bone cells.
Food and Drug Administration officials cited concerns about the drug’s increased rates of skin infections and some tumors, while outside advisers are expected to weigh the drug’s safety and effectiveness and recommend whether to approve it on Thursday.
Denosumab would have to compete against eight major types of pills and injected medicines, including estrogen and generic and brand-name Fosamax pills.
Many of the pills on the market must be swallowed once a day, week or month, the nasal spray must be inhaled daily, and one injection under the skin must be given daily.
The annual retail cost of most of those drugs can range from $385 for generic Fosamax, to roughly $1,250 for most brand-name pills, to $11,100 for injected Forteo. Genetically engineered drugs, made by altering a cell’s DNA or other genetic material, all cost more than $10,000 a year.
Data from IMS Health Global showed that sales of osteoporosis treatments, including hundreds of vitamin brands, hit nearly $8.4 billion last year among the nearly 10 million Americans living with osteoporosis.
Denosumab will pass the $1 billion annual sales threshold for blockbusters, but it’s unclear by how much, according to analyst Steve Brozak of WBB Securities.
Recent studies found denosumab caused eczema in some patients, and a dozen of the women got a serious skin infection, cellulitis, that sometimes required hospitalization for intravenous antibiotics.
All of these drugs carry some risks, said Dr. Lenore Buckley, a professor at Virginia Commonwealth University.
But Buckley said since denosumab affects the immune system, the long-term effects on cancer risk or immune function is still unknown. She expects that if the drug is approved, the FDA will require Amgen to track risks over time.
She added that the effectiveness of denosumab and existing drugs appears to plateau after two or three years.
Previous studies of osteoporosis drugs only measured changes in bone density, assumed to equate with lower fracture risk. But the newer studies also measure fracture rates.
However, independent experts say denosumab appears more effective at preventing spine fractures than three older pills – Fosamax, Actonel and Boniva – and calcitonin nasal sprays, which all use various pathways to slow down or kill cells called osteoclasts that break down bone.
Denosumab might have potential as an add-on to existing drugs to boost results, according to Dr. Jacob Warman, an osteoporosis expert at Brooklyn Hospital Center. He believes insurers who pay for multiple medicines for other conditions would cover it.
“The company has not yet set a price for the drug, but will try to keep it affordable,” said Amgen spokeswoman Kerry Beth Daly.
She added that the pricing will reflect denosumab’s twice-a-year dosing.
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