A large clinical trial of a new osteoporosis drug found that it stimulates bone growth and prevents fractures at least as well as the only other such drug on the market. The new drug, expected to win approval from federal regulators, would offer another much-needed treatment for some of the 10 million Americans, 80 per cent of them women, who have a disease that weakens bones and often leads to years of pain, disability and earlydeath. Experts agree that new drugs are urgently needed for this debilitating disease. People with osteoporosis have bones that are fragile and break easily. Bone is naturally lost with age. But osteoporosis is an extreme, abnormal bone loss that can cause devastating fractures, particularly of the spine and hip. Yet most with osteoporosis do not take medications to prevent fractures, according to the National Osteoporosis Foundation.The new drug looks promising, according to the clinical trial conducted by Radius, whose results were published Tuesday in JAMA, the journal of the American Medical Association. The trial compared the new drug, abaloparatide, with a placebo and with the only other bone-building drug on the market, Eli Lilly's Forteo.
If the Radius drug is approved, it would compete with Forteo, whose average retail price is now $3,100 for a four-week supply, said Michael Rea, the chief executive of Rx Savings Solutions, a company that provides prescription pricing information. That is triple the drug's average 2010 retail price, he said, adding that for the past three years Lilly has raised Forteo's price twice per year by 9 to 15 per cent each time.
Lilly confirmed the twice-yearly price increases and supplied wholesale prices for its drug. In 2010, Forteo's wholesale price was $947.20, and in 2016 it was $2,551.77.
Although medical specialists fervently hope the Radius drug, if approved, will cost less than Forteo, that is far from certain. Lorraine A Fitzpatrick, the chief medical officer at Radius, the small start-up that makes the new drug, declined to discuss price. If Radius's drug is approved, it will be the company's first product.
With Forteo's high price, insurers balk at covering it and even when they do, patients can face high deductibles, say doctors who treat the disease. Insurers often insist that high-risk patients first try a cheaper option, a class of drugs called bisphosphonates, which includes Fosamax. Those slow the loss of existing bone but do not build bone. They can cost just pennies a day but can have very rare side effects - a sudden shattering of the thighbone or an erosion of the jawbone. Many high-risk patients are terrified of the drug's side effects and decide to just take nothing rather than try those drugs first.
Forteo's high price is at the heart of the problem of getting the drug to those who need it, said Dolores Shoback, a professor of medicine at the University of California, San Francisco. "The cost in the private sector is getting prohibitive," she said. "You have to hunt for a reason, find a very strong reason that is ironclad," to get an insurer to approve Forteo, she added. "We find it can be extremely difficult to get it covered."
Like Forteo, the new drug must be injected daily, but it is a derivative of a different hormone - one that almost entirely stimulates bone growth. Lilly's drug stimulates both bone growth and bone loss, though the net effect is a gain in bone.
With the Radius drug, holes in osteoporotic bone appeared to fill faster than with the Lilly drug. But the study was not large enough to determine whether that translated to fewer fractures. Both drugs were far better than a placebo. After 18 months, four women of the 824 taking the Radius drug had a new spine fracture, compared with six of the 818 taking Lilly's drug and 30 of the 821 taking a placebo.
Radius has filed an application with the Food and Drug Administration to market the drug.
Osteoporosis is not one disease, and no one treatment will work for everyone, Teitelbaum said. At Washington University and other leading medical centres with a major focus on osteoporosis, doctors perform bone biopsies to decide which drug is best for a high-risk patient. Some patients lose bone too quickly. For them, a bisphosphonate or a similar injected drug, Prolia, made by Amgen, is preferred. Those who make new bone too slowly need a drug that builds it. Until now, the only such drug has been Forteo.
©2016 The New York Times News Service
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