Overweight pounds! The world's first hepatitis B treatment drug: Hepcludex is approved for sale in the European Union, the treatment of hepatitis B in Phase II clinical!

August 05, 2020 // -- MYR Pharmaceuticals is a German biotechnology company focused on the development and commercialization of drugs for the treatment of chronic hepatitis B and D.
, the company announced that the European Commission (EC) had granted its lead drug, Myrcludex B, a conditional marketing authorization (CMA) in the European Union.
Hepcludex is the first treatment in Europe to be approved for adult chronic hepatitis D virus (HDV) infection and reparation for liver disease.
The drug is a pioneering (first-in-class) virus entry inhibitor developed to treat chronic hepatitis B virus (HBV) and hepatitis B virus (HDV) infections, which inhibit HBV/HDV-like NTCP on the surface of liver cells and prevent infection of regenerative cells and the spread of the virus in the liver.
Hepcludex represents the most advanced new treatment for hepatitis D clinically.
CMA approval, based on the results of two Phase II studies (MYR202 and MYR203), the data show that Hepcludex treatment significantly reduced viralemia and improved liver function, while having good tolerance and safety.
, MYR Pharmaceuticals is currently conducting a Phase III HDV study evaluating Hepcludex's long-term treatment and a Phase II HDV study evaluating Hepcludex's joint application with polyethyl glycol interferon.
, Hepcludex's treatment of chronic hepatitis B virus (HBV) infection has also entered Phase II clinical practice.
, Hepcludex has been granted ODD status by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for the treatment of HDV infection.
addition, Hepcludex is eligible for EMA Priority Drug (PRIME) and FDA Breakthrough Drug Qualification (BTD).
prime program, similar to the BTD program, aims to accelerate the review process of key drugs in the field of pharmaceutical shortages and benefit patients as early as possible.
a drug that is not eligible for PRIME or BTD, there must be preliminary clinical evidence that the drug has a substantial clinically significant end point compared to existing therapeutic drugs.
hepcludex mechanism (click on the image: see the graph) Hepcludex was originally developed by scientists at the University of Heidelberg in Germany and the French National Institute of Health and Medical Research (INSERM).
the drug was supported by the German Centre for Infection Research (DZIF), a foundation initiated by the German Federal Ministry of Education and Research (BBF).
Professor Stephan Urban, co-inventor of hepcludex and professor of virology at the University of Heidelberg and lead scientist on the ongoing research project between MYR Pharmaceuticals and the University of Heidelberg, expressed his enthusiasm: "Today's approval marks a great achievement for those patients suffering from the most severe types of viral hepatitis, which have so far no specific treatment options.
I am pleased that, after more than 20 years of scientific and clinical research, liver cells entering the inhibitor Myrcludex B, now Hepcludex, which can be used in patients, the approval of the drug on the market will significantly improve their lives.
Origin: MYR Pharmaceuticals Receives Conditional Marketing Authorization by The European Commission for HEPCLUDEX.