A Milestone for Women’s HIV Prevention
In 2019, the European Medicines Agency (EMA) continued its review of the monthly dapivirine ring under the Article 58 procedure, which it conducts in cooperation with the World Health Organization (WHO) to help facilitate access to essential medicines in developing countries. IPM engaged with the EMA throughout the year to ensure it had the necessary information.
In July 2020, the EMA adopted a positive scientific opinion for the ring’s use by cisgender women ages 18 and older in developing countries—the first long-acting HIV prevention product and first microbicide to reach this regulatory milestone. The EMA recommended the ring in combination with safer sex practices when women cannot or choose not to use daily oral PrEP or where it is not available.
IPM’s monthly dapivirine ring is the first long-acting HIV prevention product and first microbicide to receive a positive regulatory opinion.
Linda-Gail Bekker, professor of medicine and deputy director of the Desmond Tutu Health Foundation and national principal investigator for South Africa for The Ring Study: “Offering women multiple methods like the monthly ring and daily oral PrEP is vital to controlling the epidemic and to ensuring their sexual and reproductive health and rights.”Yvette Raphael, programmes manager, Advocates for the Prevention of HIV in Africa: “Sisonke kule ring! Our daughters have a shot at an HIV-free future. This is a win for women globally and the work now starts to get our governments to approve it and make it available.”Nomfundo Eland, director, Emthonjeni Counselling and Training: “Women need HIV prevention options that they can control urgently. We are proud to have made sure that women lead the research agenda and ensured the rights of trial participants. It is a dream come true for many women!”Zeda Rosenberg, founder & CEO, IPM: “This achievement is a testament to what partnerships can accomplish.”<>
As a long-acting method with low systemic absorption that women can control themselves, the dapivirine ring can help address women’s unmet HIV prevention needs. The EMA’s decision will facilitate potential country approvals, and IPM is planning to submit the first applications through a WHO-coordinated procedure in late 2020 to African countries where the need is urgent. IPM also plans to submit to the US Food and Drug Administration in late 2020.
Where would the ring be available?
Women and girls bear a disproportionate burden of the epidemic in sub-Saharan Africa. As a nonprofit, IPM’s mission is to make safe and effective HIV prevention products available—at low or no cost—where women face high risk for HIV. Initial regulatory submissions for the ring are planned in Eswatini, Kenya, Lesotho, Malawi, Rwanda, South Africa, Tanzania, Uganda, Zambia and Zimbabwe. With sufficient resources, IPM hopes to submit applications to additional countries in Africa.