Amgen's AMG 416 has efficacy offset toxicities for FDA approval in secondary hyperparathyroidism, postmarket demands expected – experts

17 Jun 2016

Amgen’s (NASDAQ:AMGN) AMG 416’s (etelcalcetide) Phase III results for secondary hyperparathyroidism (SHPT) inspires FDA approval after statistically significant parathyroid (PTH) and phosphorus reduction outcomes, experts agreed. Although undesirable calcium (Ca) lowering and gastrointestinal (GI) toxicities were noted, treatment benefits should outweigh these concerns, they added.

Postmarket investigations, including bone density and cardiovascular (CV) impacts, may be required by the FDA, however, to gauge the toxicity extent, experts noted. AMG 416’s PDUFA date is 24 August.

SHPT, is a complication of chronic kidney disease (CKD) where enhanced PTH production occurs as an adaptive response to kidney function decline, aiming to maintain normal Ca and phosphorus levels. But excessive secretion can cause bone/joint pain and blood, immune and neurological complications and AMG 416 -- an intravenous (IV) calcimimetic -- activates the parathyroid gland’s calcium-sensing receptor, causing PTH reduction.

If approved, analysts predict peak sales of USD 750m for the drug.

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