MYR Pharmaceuticals receives positive CHMP opinion for HEPCLUDEX® (bulevirtide), the First-in-Class Entry Inhibitor for the treatment of chronic hepatitis D infections

BAD HOMBURG, Germany, May 29, 2020 /PRNewswire/ -- MYR Pharmaceuticals today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization (CMA) for the medicinal product HEPCLUDEX(®) (bulevirtide, formally known as Myrcludex B). HEPCLUDEX(®) is intended for the treatment of chronic hepatitis delta virus (HDV) infection in HDV-RNA positive adult patients with compensated liver disease. HEPCLUDEX(®) is a first-in-class entry inhibitor that binds and inactivates the essential hepatitis B (HBV) and HDV receptor on hepatocytes.

The benefit of HEPCLUDEX(®) is shown by an effective reduction of HDV RNA levels and improvement of liver inflammation.

"There is a high unmet medical need for patients suffering from chronic HDV infection," said Alexander Alexandrov, Chief Medical Officer of MYR GmbH. "We are encouraged by today´s positive CHMP opinion reinforcing the potential to become the first approved therapy for this most severe form of viral hepatitis."

The European Commission (EC) will review the CHMP recommendation and a final decision on the Conditional Marketing Authorization for HEPCLUDEX(®) in the EU is expected in the coming months. Upon positive EC decision, bulevirtide will be available under the trade name HEPCLUDEX(®) in the EU.

About HEPCLUDEX(®) (bulevirtide)
HEPCLUDEX(®) is a first-in-class entry inhibitor for treatment of chronic hepatitis B and D infections. The drug inhibits the HBV receptor (NTCP receptor) on the hepatocyte surface and prevents the infection of healthy cells and viral spread within the liver. HEPCLUDEX(®) has received Orphan Designation for treatment of HDV infection from EMA and FDA, PRIME scheme eligibility from EMA, and a breakthrough therapy designation from FDA.

About MYR Pharmaceuticals
MYR Pharmaceuticals is a German biotechnology company focused on drugs for the treatment of chronic hepatitis B and D virus infections. The company`s lead compound HEPCLUDEX(®) is currently investigated in Phase 3 study in the indication chronic hepatitis delta.

Contact Details
Thomas Christély (CFO, MYR GmbH)
Phone: +49 (0) 6172 - 49 59 811

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SOURCE MYR Pharmaceuticals