Amgen PCSK9 drug passes safety test
Amgen issued new results late yesterday from its Phase II OSLER safety trial of LDL-cholesterol lowerer and PCSK9 inhibitor evolocumab (AMG-145). The drug was "not associated with a major increase in adverse events versus standard of care (SOC)," the company said in a statement.
Findings show AEs occurred in 81.4% of patients taking evolocumab compared with 73.1% in SOC. Serious AEs surfaced in 7.1% of patients on the PCSK9 inhibitor as opposed to 6.3% in SOC.
Evolocumab's efficacy was also in line with previous reports. Mean LDL-C reductions were 52%. Previous results have shown evolomcumab's ability to lower levels by up to 59%. Amgen expects to report outcomes data from its FOURIER trial on the treatment in 2017.
Credit Suisse expects evolucumab to launch in 2016 and reach sales of $1 billion by 2020. ISI Group analyst Mark Schoenebaum estimated sales reaching the blockbuster mark by 2018.