Posted by Michael Wonder on 23 Oct 2018
MYR Pharma announces grant of breakthrough therapy designation by US FDA for Myrcludex, the first-in-class entry inhibitor for treatment of chronic hepatitis B and D infections
23 October 2018 - MYR Pharma today announced that US FDA has granted the breakthrough therapy designation for its lead compound Myrcludex. The designation is granted in the indication chronic hepatitis delta infection.
Myrcludex is a first-in-class entry inhibitor for treatment of chronic hepatitis B and D infections. The drug inhibits the HBV receptor on the hepatocyte surface and prevents the infection of healthy cells and viral spread within the liver. Myrcludex has received Orphan Designation for treatment of hepatitis delta infection from EMA and FDA, PRIME scheme eligibility from EMA, and a breakthrough therapy designation from FDA.
