July 14, 2017
Written by International Partnership for Microbicides
This article originally appeared on the International Partnership for Microbicides’s website.
SILVER SPRING, Md. (July 13, 2017) — The nonprofit International Partnership for Microbicides (IPM) is pleased to announce that its application for the monthly dapivirine vaginal ring, designed to reduce the risk of HIV-1 infection via vaginal intercourse in HIV-negative women in combination with safer sex practices, has been validated and is now under review by the European Medicines Agency (EMA). IPM designed the ring, which releases an antiretroviral drug (ARV) called dapivirine over the course of one month, to offer a discreet and long-acting HIV prevention method for women, who insert and replace it themselves.
The application was submitted under a procedure called 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.
“This marks a major next step in IPM’s regulatory strategy to make the dapivirine ring available to women across sub-Saharan Africa who currently lack the range of tools they need to stay HIV-free,” said Dr. Zeda F. Rosenberg, founder and CEO of IPM, the ring’s developer and regulatory sponsor. “Ending the epidemic will only be possible when women can choose from multiple options that meet their needs, which may change throughout their lives. As the first long-acting product, the ring would be an important addition to a comprehensive prevention package.”