EMA approved two new doravirin-based ARV drugs

The European Medicines Agency (EMA) has approved the use of drugs for the treatment of HIV Delstrigo and Pifeltro. As previously reported, the FDA issued permission for their marketing in the United States at the end of August last year.

As follows from the data published in the EMA Human Mtdicines Highlights monthly, the antiretroviral drug Delstrigo (doravirin, 100 mg / tenofovir disoproxil fumarate, 300 mg / lamivudine, 300 mg) of the pharmaceutical company MSD is intended for the treatment of HIV-1 in adults. The use of the drug is recommended in the format of "one tablet once a day." The drug is not suitable for HIV-infected patients who are resistant to lamivudine, TDF, or drugs of the same class as doravirin (non-nucleoside reverse transcriptase inhibitors).

Pifeltro (doravirin, 100 mg) is an antiviral agent intended for the treatment of adults with HIV-1, and recommended for use in combination with other ART.

We add that the US Food and Drug Administration (FDA) has decided to issue marketing permits for Delstrigo and Pifeltro at the end of August 2018, two months earlier than originally planned.