Lancet publishes Phase III data for AMG 145 in FH - Amgen

The Lancet has published data from two Phase III studies, RUTHERFORD-2 and TESLA, that showed treatment with AMG 145 (evolocumab), from Amgen, resulted in a statistically significant reduction in LDL-C compared to placebo in patients with different types of Familial Hypercholesterolemia (FH). The RUTHERFORD-2 study evaluating 329 patients with heterozygous FH (HeFH) showed that adding subcutaneous evolocumab to a stable dose of statin and other lipid-lowering therapies significantly reduced mean LDL-C by 59-66 percent from baseline compared to placebo at week 12 and weeks 10 and 12. At week 12, an LDL-C level of 70 mg/dL was achieved by 68 percent of patients treated with evolocumab 140 mg every two weeks and by 63 percent of patients treated with evolocumab 420 mg monthly, versus 2 percent of patients in the placebo groups. Similar results were seen for the mean of weeks 10 and 12 . The most common adverse events were nasopharyngitis, headache, contusion (i.e., bruise), back pain and nausea.

The TESLA study evaluating 49 patients with homozygous FH (HoFH), not on apheresis, showed that adding evolocumab 420 mg subcutaneous monthly to a stable dose of statin therapy and other lipid-lowering medications significantly reduced LDL-C by 31 percent from baseline at week 12 compared to placebo. In patients with at least one defective LDL receptor mutation, evolocumab reduced LDL-C by 41 percent (95 percent CI, -53, -28, p<0.0001) compared to placebo. the most common aes were upper respiratory tract infection influenza gastroenteritis and nasopharyngitis.>

See: "PCSK9 Inhibition with Evolocumab (AMG 145) in Heterozygous Familial Hypercholesterolaemia: Results of a Randomised, Double-blind, Placebo-controlled Trial."
"Inhibition of PCSK9 with Evolocumab in Homozygous Familial Hypercholesterolaemia: Results of a Randomised, Double-blind, Placebo-controlled Trial."
Raal F et al.
Lancet. 2014. In press.