Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
MYR Pharmaceuticals is a German biotechnology company focused on the development and commercialization of therapeutics for the treatment of chronic hepatitis B (HBV) and D (HDV) infections. The company’s lead compound bulevirtide (Myrcludex) is a first-in-class entry inhibitor for treatment of chronic HVB and HDV and is currently in a Phase 3 study in the indication of chronic HDV.
The drug inhibits the NTCP receptor on the hepatocyte surface and prevents the infection of healthy cells and viral spreading within the liver. Bulevirtide has received the Orphan Drug Designation for treatment of HDV infection from the European Medicines Agency (EMA) and from the U.S. Food & Drug Administration (FDA). In addition, the EMA has granted PRIority MEdicines (PRIME) scheme eligibility. In parallel the FDA has granted Breakthrough Therapy designation and the British Medicines and Healthcare products Regulatory Agency (MHRA) has recently issued the Promising Innovative Medicine (PIM) designation.
As an inhibitor of bile acid transporter NTCP, bulevirtide (Mycludex) also opens up new possibilities for the treatment of a variety of inflammatory and metabolic diseases.