Pharmaceutical Business review

FDA clears Affymax Omontys injection

Omontys injection is a synthetic, pegylated, peptide-based erythropoiesis stimulating agent (ESA).

Nektar provides its partner Affymax with its proprietary PEGylation technology for use in Omontys.

Two Phase 3 dialysis studies (EMERALD 1 and 2) evaluated the safety and efficacy of Omontys, dosed once monthly, compared to epoetin alfa or beta, dosed one-to-three times per week.

In the studies, the primary efficacy endpoint was a mean change in Hb between baseline and evaluation period following entry into the study.