November 30, 2020
1 min read
The dapivirine vaginal ring has been prequalified by WHO, bringing the HIV preventive closer to public introduction and approval by individual countries.
The prequalification designation signifies WHO’s stamp of approval that the device meets global standards for quality, safety and efficacy in reducing women’s risk for HIV infection.
According to a press release from the nonprofit International Partnership for Microbicides (IPM), which developed the dapivirine ring and is the product’s regulatory sponsor, women bear a disproportionate burden of the HIV/AIDS epidemic, with nearly 60% of new adult cases in sub-Saharan Africa occurring among women.
The monthly dapivirine ring was previously reported to reduce HIV risk by 39% in the HOPE trial.
Zeda F. Rosenberg, ScD, founder and chief executive officer of the IPM, said in a press release. “Our aim is to make the ring available first in sub-Saharan Africa, where women face persistently high HIV risk.”
According to the press release, the IPM received the rights to develop dapivirine as a vaginal microbicide from Johnson & Johnson, which is partnering with the group to plan the ring’s introduction.
The IPM says it will initially seek approvals for the ring’s use in eastern and southern Africa where “the need is urgent,” and will also submit an application to the FDA in 2020.