The Food and Drug Administration recently approved a new drug made by Miami-based Opko Health.
Rayaldee, known by the generic name calcifediol, provides a new treatment option for people with secondary hyperparathyroidism, a disease which causes the release of too much parathyroid hormone in the blood and is often associated with vitamin D deficiency in adults with stage three or four chronic kidney disease.
In phase three clinical trials, patients treated with the drug experienced a reduction of at least 30 percent in parathyroid hormone levels in the blood compared to those taking a placebo. Rayaldee also corrected vitamin D deficiency in more than 80 percent of patients taking the drug compared to just 8 percent of patients on the placebo.
"FDA's approval of Rayaldee represents an important milestone for Opko," said Phillip Frost, MD, CEO and chairman of Opko. "Rayaldee is the first product to receive FDA approval for this important indication and is one of Opko's many pharmaceutical products being developed for significant medical problems, which will benefit from new treatment options."
Opko expects Rayaldee to hit the market later this year.
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