The European Medicines Agency (EMA) published a positive opinion on the use of the dapivirine vaginal ring for women ages 18 and older in developing countries to reduce their risk of HIV-1 infection. The monthly ring is the first long-acting HIV prevention product and is designed to help address women’s unmet need for new prevention methods given the persistently high rates of HIV they face, especially in sub-Saharan Africa.
The ring is designed to help reduce women’s HIV risk during vaginal sex. Women insert the product themselves and replace it every month. Made of flexible silicone, the ring slowly releases the ARV dapivirine locally to the site of potential infection, with minimal absorption elsewhere in the body.
The EMA’s Committee for Medicinal Products for Human Use reviewed the ring under the Article 58 procedure, which it conducts in cooperation with the World Health Organization (WHO) to facilitate access to essential medicines in low- and middle-income countries using the same rigorous standards for products intended for use in the European Union. The next steps include acquiring national approvals and starting the roll-out of the ring in different countries.
The ring should provide women with more options to protect themselves from HIV, as women still carry the biggest burden of the HIV epidemic in Subsaharan Africa, with about 1.400 new infections among women a day. The ring was developed by the International Partnership for Microbicides (IPM), with contributions by donor governments, including the Flemish government.
The EMA’s Committee for Medicinal Products for Human Use reviewed the ring under the Article 58 procedure, which it conducts in cooperation with the World Health Organization (WHO) to facilitate access to essential medicines in low- and middle-income countries using the same rigorous standards for products intended for use in the European Union. The next steps include acquiring national approvals and starting the roll-out of the ring in different countries.
The ring should provide women with more options to protect themselves from HIV, as women still carry the biggest burden of the HIV epidemic in Subsaharan Africa, with about 1.400 new infections among women a day. The ring was developed by the International Partnership for Microbicides (IPM), with contributions by donor governments, including the Flemish government.