The Committee on medical use of the European Agency of medicines (EMA) recommended granting marketing authorization under special conditions the drug boulevarde the first drug for the treatment of viral hepatitis D. this was reported in the press release of the company of MYR Pharmaceuticals, which owns the rights to the drug in the EU and the USA.
In Russia the right to Bulevardi belong to the company Hepatera, the drug was registered in the domestic market in November 2019 under the trade name Mercedes B. EU boulevarde to be sold under a different TN – Galloudec (Hepcludex).
The final decision on registration of the drug will be taken by the European Commission in the coming months.
Special conditions for granting marketing permissions are associated with a large unmet need for therapies for patients with chronic hepatitis D (hepatitis B with Delta-agent).Boulevarde is the first drug to treat the infection. At the end of last year, the U.S. administration on control over products and medicines (FDA) granted it the status of breakthrough therapy.
I and phase II clinical studies bulevardia were conducted in medical institutions of Russia and Germany. The phase III studies, which are ongoing, are in Russia, Germany, Sweden, USA, Italy, France, Moldova, Georgia, Romania.