New osteoporosis drug awaits FDA’s OK
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 percent of them women, who have a disease that weakens bones and often leads to years of pain, disability and early death.
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. Firm’s first product
The new drug looks promising, according to the clinical trial conducted by Radius, whose results were published this past week in Journal of the American Medical Association. The trial compared the new drug, abaloparatide, with a placebo and with the only other bonebuilding 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 percent 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. Dr. Lorraine A. Fitzpatrick, the chief medical officer at Radius, the small startup that makes the new drug, declined to discuss price. If Radius’ drug is approved, it will be the company’s first product. A cheaper option
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.
Bisphophonates slow the loss of existing bone but do not build bone. They can cost just pennies a day but can have 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.
“I see this all the time,” said Dr. Steven L. Teitelbaum, an osteoporosis specialist at Washington University School of Medicine, who was not involved in the clinical trial of the new drug. “Patients go untreated.” The price of Forteo, he said, is “obscene.”
J. Scott MacGregor, a Lilly spokesman, said in an email that “the rhetoric on drug pricing represents a disingenuous debate — pitting cost against value.” He added that Lilly had programs to assist patients with payments and that it negotiated prices with insurers. And, he said, Forteo is expensive to make.
Like Forteo, the new drug must be injected dai- ly, 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 U.S. Food and Drug Administration to market the drug.