Created in Russia, the cure for hepatitis D received the status of "breakthrough therapy" in the United States

This drug will appear on the Russian market at the end of 2019. MOSCOW, December 17. / TASS /. The world's first drug from previously incurable hepatitis D, created by a resident of the Skolkovo Foundation by the biotechnology company Hepatera, received the status of “breakthrough therapy” from the US Food and Drug Administration (FDA). This was reported on Monday by the press service of the fund.

“The drug Myrcludex B, created by the resident of the Skolkovo Foundation by the biotechnological company Hepatera, received the status of“ breakthrough therapy ”from the US Food and Drug Administration (FDA). Myrcludex B is the world's first medicine for previously incurable hepatitis D. It is also effective for treating hepatitis B, ”the report says.
Getting the status of "breakthrough therapy" from the FDA means that international experts in the field of drug development and testing confirm the effectiveness of the drug.
In the future, it will simplify the delivery of drugs to the markets of the United States and Europe. It is noted that the effectiveness and safety of the drug was proven during research in leading clinics in Russia and Germany. This drug will appear on the Russian market at the end of 2019.

Myrcludex B was created on the basis of research by scientists from the University of Ruprecht and Karl (Ruprecht-Karls-Universitt Heidelberg) and is being developed in the framework of international cooperation with the biotechnology company MYR Pharma, GmbH (Germany). Myrcludex B blocks the receptor through which viral particles penetrate the liver cells. As a result, the further spread of inflammation and the development of dangerous complications are prevented. When protein is blocked, viruses remain outside the cells, where they are destroyed by the body’s immune system.
Hepatera is developing a first-class drug for the treatment of chronic hepatitis B with a delta agent - the most severe viral liver disease, affecting about 15 million people worldwide. To date, there is no registered standard therapy in 90% of patients, and in 10% of patients there is an extremely low efficacy of treatment with a single prescribed drug, pegylated interferon (PEG-IFN)
Camila Zarubina
Director of Acceleration, Cluster of Biological and Medical Technologies of the Skolkovo FoundationThe World Health Organization estimates that around 257 million people in the world now have hepatitis B.

About 15 million of them are infected with hepatitis D (develops only when hepatitis B is present). Patients infected with hepatitis D have a high probability of developing a terminal stage of liver failure as a result of an acute infection, rapid development of cirrhosis of the liver, and in the case of chronic infections, the likelihood of hepatocellular carcinoma (liver cancer). Every year, acute viral hepatitis takes almost half a million lives - more than HIV infection, malaria and tuberculosis.
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