The recent first global approval of pemafibrate has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs, based on the development milestones tracked in AdisInsight.
In July 2017, pemafibrate (Parmodia®), developed by Kowa Company, received its first global approval in Japan for the treatment of hyperlipidaemia (including familial hyperlipidaemia). Pemafibrate is an oral, peroxisome proliferator-activated receptor (PPAR)-α agonist. PPAR-α is expressed in the liver, selective binding by pemafibrate regulates the expression of target genes resulting in a decrease in plasma triglyceride levels and an increase in levels of high-density lipoprotein (HDL) cholesterol.
Pemafibrate is undergoing phase III development in Japan, the US and a number of European countries for the treatment of dyslipidaemias and is also in phase III development for the treatment of hypertriglyceridaemia in the US and Eastern Europe.
In clinical trials permafibrate appears to have been generally well tolerated. However, the prescribing information warns against the possibility of rhabdomyolysis in combination with other fibrates and/or HMG-CoA reductase inhibitors, although this had not been observed in clinical trials.
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