Amgen reports evolocumab data in hoFH

Amgen Inc. (NASDAQ:AMGN) said once-monthly subcutaneous evolocumab ( AMG 145) met the primary endpoint of a greater percent reduction in LDL-C from baseline to week 12 vs. placebo in the double-blind Phase III portion of the Phase II/III TESLA trial to treat homozygous familial hypercholesterolemia (hoFH). The Phase III portion of TESLA enrolled 49 patients with hoFH who were on a stable dose of statin therapy and lipid-lowering medication. Last year, Amgen reported data from eight hoFH patients in the single-arm, open-label Phase II portion of TESLA showing that once-monthly evolocumab led to a 17% mean reduction in LDL-C from baseline to week 12.

Amgen plans to submit global regulatory applications for evolocumab this year, but declined to disclose details. The company has previously reported data from five other Phase III trials evaluating the human mAb against proprotein convertase subtilisin/kexin type 9 (PCSK9). Amgen gained $1.32 to $123.86 on Monday. ...