The FDA has approved Opko’s Rayaldee, a full four months ahead of its PDUFA date.
The drug was approved to treat secondary hyperparathyroidism in adults with stage three or four chronic kidney disease with Vitamin D deficiency. Data from two double blinded Phase 3 trials showed that the drug corrected Vitamin D insufficiency in more than 80 percent of patients, as compared with less than 7 percent of patients in the placebo group. Possible side effects include elevated serum calcium, adynamic bone disease and an increased risk of bone fractures.
In March, the company landed a complete response letter for the drug over third-party manufacturer deficiencies cited in a Form 483.