The ID Pipeline: FDA Activity From the Week of February 9, 2020

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of February 9, 2020.

Phase 3 Trial to Evaluate Dapivirine Ring Among Pregnant Women

The National Institutes of Health (NIH) has launched the first clinical trial evaluating the safety of a monthly dapivirine ring among pregnant women in eastern and southern Africa. The NIH-funded trial will also assess the safety of daily oral emtricitabine/tenofovir disoproxil fumarate, to compare the acceptability and use of these 2 HIV prevention measures.

The vaginal ring works by slowly releasing the non-nucleoside reverse transcriptase inhibitor dapivirine, and is replaced every month.

The trial, known as “DELIVER: A Phase 3b Safety Study of the Dapivirine ring and PrEP in Pregnant Women,” will enroll 750 women who are not living with HIV between 18-40 years of age who have are currently pregnancy.

Enrolled participants will be randomly assigned to receive either the dapivirine vaginal ring or PrEP in a 2-to-1 ratio. Participants will use the regimen until the end of their pregnancy or 42 weeks gestation, depending on which time point occurs first.

Remdesivir Prevents MERS Coronavirus in Monkeys

NIAID has announced that the experimental antiviral remdesivir prevented rhesus macaques who were infected with Middle East respiratory syndrome coronavirus.

The agent prevented disease when administered before infection and also improved the condition of macaques when given after animals were already infected.

The findings of this research support additional trials of remdesivir for both MERS-CoV and COVID-19. Several clinical trials for COVID-19 are underway in China.

The Biomedical Advanced Research and Development Authority, part of the US Department of Health and Human Services provided support for the study and Gilead Sciences developed remdesivir.