The recent first global approval of pemafibrate has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2].

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.[1]

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.[2]

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.[1]

For further information related to the first approval of pemafibrate please visit Drugs[1],  or to learn more about the overall development of pemafibrate  across all indications visit AdisInsight[2].

Image credit: wildpixel / Getty Images / iSt

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.