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28 八月 2018, 10:45
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EMA will consider the application for registration of the drug for the treatment of HIV infection Trogarzo

EMA will consider the application for registration of the drug for the treatment of HIV infection Trogarzo - 图片 1

On Tuesday, August 28, the Canadian pharmaceutical company Theratechnologies announced the filing of documents for the registration of the innovative drug for the treatment of HIV-1 with multiple drug resistance (MDR HIV-1) Trogarzo (ibalizumab) to the European Medicines Agency (EMA). Previously, the tool has already received approval in the US.

According to the press release of the organization, until the middle of September the European regulator will conduct a primary assessment of the documentation for Trogarzo and will decide on the possibility of accelerated registration of the drug.

The expedited registration procedure, which is spoken at the company, provides for a shorter period for evaluating the documentation (including information on the safety and effectiveness of the facility) from 210 to 150 days.

As the basis for the registration of the drug, Theratechnologies, the same data as those filed earlier with the US Food and Drug Administration (FDA) were submitted.

Note that the decision to initiate the process of registration of a monoclonal antibody in Europe, the developers said at the end of April. Then the reason for the statements were the results of a number of meetings with representatives of the regulators of the Netherlands, Italy and EMA.

"Europe is the second most important market for Trogarzo. [...] Knowing that the product will be able to give patients who are in different treatment regimens but still have a detectable viral load, we spared no effort to guarantee the filing of the Trogarzo registration application within six months after receiving approval in the United States, "- Luc Tanguay, president and CEO of Theratechnologies Inc., commented on the company's decision.

照片: Mosmedpreparaty

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