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|Amgen Announces Positive Top-Line Results From Second Phase 3 Study Of AMG 416 For The Treatment Of Secondary Hyperparathyroidism In Patients With Chronic Kidney Disease Receiving Hemodialysis|
In the AMG 416 group, 74.0 percent of patients achieved a > 30 percent reduction from baseline in PTH compared with 8.3 percent in the placebo arm, a statistically significant result. Secondary endpoints included the percent change from baseline during the EAP in serum phosphorus (P) concentration (mean changes of -7.71 and -1.31 percent among patients in the AMG 416 and placebo arms, respectively) and corrected calcium (cCa) concentration (mean changes of -7.29 and 1.18 percent among patients in the AMG 416 and placebo arms, respectively). Both of these secondary endpoint results were statistically significant.
"The results from this second Phase 3 study help to confirm that AMG 416 could become an important new treatment option for dialysis patients with secondary hyperparathyroidism," said
Treatment-emergent adverse events (TEAEs) were reported in 91.6 and 78.7 percent of patients who received AMG 416 and placebo, respectively. TEAEs that were reported in > 10 percent of patients who received AMG 416 included (AMG 416 vs. placebo, respectively): blood calcium decreased (61.0 and 8.3 percent), nausea (12.4 and 5.1 percent), muscle spasms (12.0 and 7.1 percent) and vomiting (10.4 and 7.1 percent). TEAEs of hypocalcemia (symptomatic) were reported in 7.2 percent of patients who received AMG 416 versus 0.4 percent in the placebo group. Serious adverse events (SAEs) were reported in 27.1 and 30.7 percent of patients who received AMG 416 and placebo, respectively.
Secondary endpoints included the proportion of patients with PTH ≤ 300 pg/mL during the EAP and the percent change from baseline during the EAP in values for PTH, serum cCa, corrected calcium-phosphorus product (cCa x P) and P.
About Secondary Hyperparathyroidism
About AMG 416
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