PCSK9 inhibitors have similar safety profile to current standard of care

Preliminary analysis of PCSK9 inhibitors showed that they have a similar safety profile to the current standard of care, US pharma major's Pfizer’s (NYSE: PFE) Lipitor (atorvastatin) in treating hypercholesterolemia.

The report from regulatory specialists AdverseEvents comes in advance of the FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting on June 10 2015, which will discuss the safety and efficacy of evolocumab, marketed as Repatha by Amgen (Nasdaq: AMGN), a leading independent biotech firm. It is being evaluated as adjunct to diet to reduce low-density lipoprotein cholesterol in various populations.

Analysis showed that anti-PCSK9s such as evolocumab and alirocumab, marketed as Praluent by Sanofi (Euronext: SAN) and Regeneron (Nasdaq: REGN) have a similar safety profile to Lipitor with additional risks reported during clinical trials for injection site adverse events, antibody-related adverse events and neurocognitive adverse events. Lipitor’s label, however, shows adverse events related to hepatic issues, toxic epidermal necrolysis, Steven-Johnsons Syndrome and pancreatitis, which had not been reported for the anti-PCSK9s in their respective clinical trials that AdverseEvents evaluated. The alirocumab clinical trial showed an increased rate of ophthalmic events compared to placebo (2.9% versus 1.9%) that was not reported in any of the evolocumab trials.