Dapivirine Vaginal Ring
The first microbicide to be submitted for regulatory approval, the dapivirine vaginal ring, developed by the International Partnership for Microbicides (IPM) for HIV prevention, received a positive opinion from the European Medicines Agency (EMA) in July of 2020.
The ring, made of silicone, is inserted in the vagina and slowly releases dapivirine, an antiretroviral drug, over the course of one month. It is woman-controlled (a woman inserts and removes the ring herself) and releases active drug at the site of potential infection in the vagina, with very low systemic uptake (affecting the whole body).
IPM, the ring's developer, applied to the European Medicines Agency (EMA) for review of the ring under Article 58. This procedure allows the EMA, in cooperation with the World Health Organization (WHO), to provide a scientific opinion on the safety, efficacy and quality of medicines that would be marketed exclusively outside of the European Union—specifically in low- and middle-income countries—for diseases of major public health interest.
In July of 2020, the EMA gave a positive scientific opinion on the public health benefits of the ring for use by women in low- and middle-income countries outside of the European Union. The positive opinion also said there should be a commitment to do a post-authorization efficacy study. This study would enroll cisgender women aged 18-25 to better understand efficacy, and to complement existing data on potential drug resistance. The EMA’s positive opinion helps move the ring from a research product to a real tool that women can use.
The WHO can now convene a guideline development committee to review the dapivirine vaginal ring as part of its HIV/AIDS treatment and prevention guidelines with possible recommendations on the ring’s use. WHO may also now begin to “prequalify” the ring, a process to evaluate whether a medicine meets global standards for quality, safety and efficacy. WHO prequalification can facilitate national regulatory review and guideline development. Many African national regulatory agencies use WHO prequalification to determine which new products they approve.
IPM also plans to submit regulatory applications to the US Food & Drug Administration (FDA) and to various African regulatory bodies.
For the latest information, visit IPM's website here.
Planning for Introduction
A robust plan for ring introduction is in place and the positive EMA opinion moves the ring closer to potential introduction and scale-up in communities where it is most needed. IPM has chosen to focus its initial planning for introduction in Kenya, Malawi, Rwanda, South Africa, Tanzania, Uganda and Zimbabwe.
These countries were selected due to the public health need and their participation in ring studies, which could facilitate the product’s introduction if it is approved. This planning involves studies, information gathering and collaboration with many organizations and key stakeholders.
Evidence and Research
Information on Phase III trials, open label extension studies, ring studies involving adolescent girls and young women, and pregnancy and breastfeeding studies is available below.
Additional resources are available on planning for introduction, learning about the potential impact of the ring, marketing, demand creation and advocacy. For a one-page overview of ring resources, click here.
Last updated August 13, 2020.